Flutamide in unresectable pancreatic adenocarcinoma: a randomized, double-blind, placebo-controlled trial.

Abstract:

PURPOSE:To evaluate the impact of flutamide on survival of patients with unresectable pancreatic cancer. METHODS:This single institution, randomized, double-blind, placebo controlled study compared flutamide in the dose of 250 mg three times daily (n = 23) versus placebo (n = 23) in patients with histologically proven, previously untreated unresectable pancreatic adenocarcinoma. The primary end point was overall survival; secondary endpoints included 6-month and 1-year survival rates, performance status and response rate. RESULTS:Both the groups were well matched with regards to demographic, disease related and treatment variables. This small sample sized study, failed to demonstrate a dramatic effect on survival with the use of flutamide. Median overall survival was 151 days with the use of flutamide as compared to 136 with placebo (p = 0.51). The 6-month survival rate was 39.13% in both arms of study and 1-year survival was 4.35% versus 13.04% for the flutamide group. There was no statistically significant difference in time to deterioration of performance status (flutamide 90 days versus placebo 68 days, p = 0.59) and all patients died as a result of tumor progression. CONCLUSIONS:Anti-androgen drug flutamide in the dose of 250 mg three times daily does not appear to prolong overall survival in unresectable pancreatic cancer.

journal_name

Invest New Drugs

authors

Negi SS,Agarwal A,Chaudhary A

doi

10.1007/s10637-005-3536-2

subject

Has Abstract

pub_date

2006-05-01 00:00:00

pages

189-94

issue

3

eissn

0167-6997

issn

1573-0646

journal_volume

24

pub_type

杂志文章,随机对照试验
  • Phase II trial of doxorubicin and trifluoperazine in metastatic breast cancer.

    abstract::Pre-clinical and clinical studies have shown that trifluoperazine (TFP) can modulate multidrug resistance. We have performed a Phase II trial of TFP and doxorubicin in doxorubicin-naive patients with metastatic breast cancer. We hypothesized that TFP would inhibit the development of doxorubicin resistance, resulting i...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00873916

    authors: Budd GT,Bukowski RM,Lichtin A,Bauer L,Van Kirk P,Ganapathi R

    更新日期:1993-02-01 00:00:00

  • Multicenter phase II study of the AKT inhibitor MK-2206 in recurrent or metastatic nasopharyngeal carcinoma from patients in the mayo phase II consortium and the cancer therapeutics research group (MC1079).

    abstract:BACKGROUND:This study investigated the activity of MK-2206, an AKT inhibitor, in metastatic or recurrent nasopharyngeal carcinoma (NPC). METHOD:Oral MK-2206 at a dose of 200 mg was administered on days 1, 8, 15 and 22 of a 28-day cycle until progression. Plasma EBV DNA clearance during the first month of treatment was...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-015-0264-0

    authors: Ma BB,Goh BC,Lim WT,Hui EP,Tan EH,Lopes Gde L,Lo KW,Li L,Loong H,Foster NR,Erlichman C,King AD,Kam MK,Leung SF,Chan KC,Chan AT

    更新日期:2015-08-01 00:00:00

  • The effects of the anti-tumor agent mezerein on the cytotoxic capacity and oxidative metabolism of human blood cells.

    abstract::Mezerein, the most active antitumor compound isolated from the daphne species of plants, has a structural similarity to phorbol myristate acetate (PMA), the major active compound isolated from croton oil. PMA is known to have tumor promoting activity and is a potent inflammatory agent. Mezerein has similarly been repo...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00170855

    authors: Barton K,Randall G,Sagone AL Jr

    更新日期:1989-07-01 00:00:00

  • A phase 1 dose-escalating study of pegylated recombinant human arginase 1 (Peg-rhArg1) in patients with advanced hepatocellular carcinoma.

    abstract:BACKGROUND:Hepatocellular carcinoma (HCC) cells are auxotrophic for arginine, depletion of which leads to tumour regression. The current study evaluated safety, pharmacokinetics (PK)/ pharmacodynamics (PD) parameters, and potential anti-tumor activity of pegylated recombinant human arginase 1 (peg-rhArg1) in advanced H...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-012-9807-9

    authors: Yau T,Cheng PN,Chan P,Chan W,Chen L,Yuen J,Pang R,Fan ST,Poon RT

    更新日期:2013-02-01 00:00:00

  • Nafazatrom: clonogenic in-vitro assessment of activity against human malignancies.

    abstract::Nafazatrom was tested against a variety of human malignancies with the human tumor stem cell assay at one or more of the following concentrations: 1, 10, 25, and 100 micrograms/ml X 1 h or 0.05, 0.5, or 5 micrograms/ml by continuous exposure. Major (greater than or equal to 70%) inhibition was noted in 7/52 adenocarci...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00173781

    authors: Haas CD,Kyle GW,Crissman JD,Schaldenbrand MF

    更新日期:1984-01-01 00:00:00

  • Phase I study of mitonafide in 120 hour continuous infusion in non-small cell lung cancer.

    abstract::Mitonafide is the lead compound of a new series of antitumor drugs, the 3-Nitronaphthalimides, which have shown antineoplastic activity in vitro as well as in vivo. This phase I Mitonafide study in non-small cell lung cancer using a 120-hour continuous infusion (120 h. C.I.) schedule of administration was designed to ...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00877242

    authors: Rosell R,Carles J,Abad A,Ribelles N,Barnadas A,Benavides A,Martin M

    更新日期:1992-08-01 00:00:00

  • SHetA2 interference with mortalin binding to p66shc and p53 identified using drug-conjugated magnetic microspheres.

    abstract::SHetA2 is a small molecule flexible heteroarotinoid (Flex-Het) with promising cancer prevention and therapeutic activity. Extensive preclinical testing documented lack of SHetA2 toxicity at doses 25 to 150 fold above effective doses. Knowledge of the SHetA2 molecular target(s) that mediate(s) the mechanism of SHetA2 a...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-013-0041-x

    authors: Benbrook DM,Nammalwar B,Long A,Matsumoto H,Singh A,Bunce RA,Berlin KD

    更新日期:2014-06-01 00:00:00

  • Phase 1 study of the oral histone deacetylase inhibitor abexinostat in patients with Hodgkin lymphoma, non-Hodgkin lymphoma, or chronic lymphocytic leukaemia.

    abstract::Background We determined the safety, pharmacokinetics, pharmacodynamics, and antitumour activity of abexinostat in B-cell lymphoma or chronic lymphocytic leukaemia. Patients and methods Thirty-five patients received oral abexinostat 30, 45, or 60 mg/m(2) bid in a 3 + 3 design in three 21-day schedules: 14 days on trea...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-015-0206-x

    authors: Morschhauser F,Terriou L,Coiffier B,Bachy E,Varga A,Kloos I,Lelièvre H,Sarry AL,Depil S,Ribrag V

    更新日期:2015-04-01 00:00:00

  • Kidney injuries related to ipilimumab.

    abstract::Monoclonal antibodies directed against the immune checkpoint protein cytotoxic T-lymphocyte antigen-4 (CTLA-4; CD152) have been investigated in metastatic melanoma and other cancers and have shown promising results. Inhibition of CTLA-4 characteristically induces well-known side effects called "immune-related adverse ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-014-0092-7

    authors: Izzedine H,Gueutin V,Gharbi C,Mateus C,Robert C,Routier E,Thomas M,Baumelou A,Rouvier P

    更新日期:2014-08-01 00:00:00

  • Phase 1 clinical trial of the novel proteasome inhibitor marizomib with the histone deacetylase inhibitor vorinostat in patients with melanoma, pancreatic and lung cancer based on in vitro assessments of the combination.

    abstract:PURPOSE:Combining proteasome and histone deacetylase (HDAC) inhibition has been seen to provide synergistic anti-tumor activity, with complementary effects on a number of signaling pathways. The novel bi-cyclic structure of marizomib with its unique proteasome inhibition, toxicology and efficacy profiles, suggested uti...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-011-9766-6

    authors: Millward M,Price T,Townsend A,Sweeney C,Spencer A,Sukumaran S,Longenecker A,Lee L,Lay A,Sharma G,Gemmill RM,Drabkin HA,Lloyd GK,Neuteboom ST,McConkey DJ,Palladino MA,Spear MA

    更新日期:2012-12-01 00:00:00

  • Irinotecan and DNA-PKcs inhibitors synergize in killing of colon cancer cells.

    abstract::This study sought to measure the degree of synergy induced by specific small molecule inhibitors of DNA-PK [NU7026 and IC486241 (ICC)], a major component of the non-homologous end-joining (NHEJ) pathway, with SN38 or oxaliplatin. Synergy between the DNA damaging drugs and the DNA-PK inhibitors was assessed using the s...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-010-9626-9

    authors: Davidson D,Coulombe Y,Martinez-Marignac VL,Amrein L,Grenier J,Hodkinson K,Masson JY,Aloyz R,Panasci L

    更新日期:2012-06-01 00:00:00

  • Phase II study of vinorelbine monotherapy in anthracycline and taxane pre-treated metastatic breast cancer.

    abstract::We performed a single-institution phase II study to evaluate the efficacy and toxicities of vinorelbine monotherapy in patients previously treated with anthracyclines and taxanes. Vinorelbine was administered at a dose level of 25 mg/m² intravenously on days 1, 8, 15 and 22, every four weeks, and responses were assess...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-009-9357-y

    authors: Seo HY,Lee HJ,Woo OH,Park KH,Woo SU,Yang DS,Kim AR,Lee JB,Lee ES,Kim YH,Kim JS,Seo JH

    更新日期:2011-04-01 00:00:00

  • Cyclosporine and alpha-difluoromethylornithine exhibit differential effects on colon and pancreatic cancer in vitro.

    abstract::alpha-Difluoromethylornithine (DFMO) is a known irreversible inhibitor of ornithine decarboxylase (ODC), the rate-limiting enzyme in polyamine biosynthesis. Cyclosporine (CsA) has been reported to inhibit ODC activity in vitro. In the present study, we compared the effects of DFMO and CsA on growth, survival, and poly...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00175295

    authors: Saydjari R,Townsend CM Jr,Barranco SC,Thompson JC

    更新日期:1987-01-01 00:00:00

  • Phase II trial of topotecan in patients with cisplatin-refractory germ cell tumors.

    abstract::Fifteen patients with advanced, cisplatin-refractory germ cell tumors (GCT) were treated on a phase II trial with topotecan. None of the 14 evaluable patients achieved a complete or partial response. Myelosuppression was the major toxicity. The median nadir leukocyte count was 1.75 cells/mm3, neutrophil count was 1.55...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00872866

    authors: Puc HS,Bajorin DF,Bosl GJ,Amsterdam A,Motzer RJ

    更新日期:1995-01-01 00:00:00

  • Trimetrexate in advanced carcinoma of the esophagus.

    abstract::Twenty-four patients with advanced epidermoid carcinoma of the esophagus were treated with trimetrexate (TMTX), a lipid soluble non-classical antifol. Patients were given TMTX 8 mg/m2 intravenously day 1-5 every 28 days. In nine of these patients the dose was escalated to 12 mg/m2 day 1-5 every 28 days. Three patients...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00173651

    authors: Alberts AS,Falkson G,Badata M,Terblanche AP,Schmid EU

    更新日期:1988-12-01 00:00:00

  • Phase I/II study of docetaxel, ifosfamide, and doxorubicin in advanced, recurrent, or metastatic soft tissue sarcoma (STS).

    abstract:BACKGROUND:Based on reports of the efficacy of docetaxel (T) in STS, we undertook a phase I/II trial to determine the response rate (RR), dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of addition of T to doxorubicin (A) and ifosfamide (I) in advanced STS. METHODS:Patients with advanced, recurrent, or ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-006-9035-2

    authors: Suppiah R,Wood L,Elson P,Budd GT

    更新日期:2006-11-01 00:00:00

  • Phase 2 study of CT-322, a targeted biologic inhibitor of VEGFR-2 based on a domain of human fibronectin, in recurrent glioblastoma.

    abstract::VEGF signaling through VEGFR-2 is the major factor in glioblastoma angiogenesis. CT-322, a pegylated protein engineered from the 10th type III human fibronectin domain, binds the VEGFR-2 extracellular domain with high specificity and affinity to block VEGF-induced VEGFR-2 signaling. This study evaluated CT-322 in an o...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s10637-014-0186-2

    authors: Schiff D,Kesari S,de Groot J,Mikkelsen T,Drappatz J,Coyle T,Fichtel L,Silver B,Walters I,Reardon D

    更新日期:2015-02-01 00:00:00

  • Primary tumor, lung and kidney retention and antimetastasis effect of NAMI-A following different routes of administration.

    abstract::Imidazolium-trans-dimethylsulfoxideimidazoletetrachlororuthenate (NAMI-A) is a ruthenium compound effective on solid tumor metastases. In this study, we evaluated the effects of different routes of administration of NAMI-A on the distribution to primary tumor, lungs and kidneys in BD2F1 hybrids with Lewis lung carcino...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1023/a:1022916310694

    authors: Cocchietto M,Zorzet S,Sorc A,Sava G

    更新日期:2003-02-01 00:00:00

  • Echinomycin: the first bifunctional intercalating agent in clinical trials.

    abstract::Echinomycin is a quinoxaline antibiotic that was originally isolated from Streptomyces echinatus. Based on its antitumor activity against two i.p. implanted murine tumors, the B16 melanoma, and the P388 leukemia, it was brought into clinical trials by the National Cancer Institute. Recent studies on its cytotoxic acti...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章,评审

    doi:10.1007/BF00170766

    authors: Foster BJ,Clagett-Carr K,Shoemaker DD,Suffness M,Plowman J,Trissel LA,Grieshaber CK,Leyland-Jones B

    更新日期:1985-01-01 00:00:00

  • Risk factors for cancer-associated thrombosis in patients undergoing treatment with immune checkpoint inhibitors.

    abstract::Purpose Anticancer agents are known to increase cancer-associated thrombosis (CAT) onset. CAT onset rate is reported to be 1.92% in cisplatin-based therapy, 6.1% in paclitaxel plus ramucirumab combination therapy, and 11.9% in bevacizumab monotherapy. Because immune checkpoint inhibitors (ICIs) cause a sudden increase...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-019-00881-6

    authors: Ando Y,Hayashi T,Sugimoto R,Nishibe S,Ito K,Kawada K,Ikeda Y,Yamada S,Imaizumi K

    更新日期:2020-08-01 00:00:00

  • Phase II trial of PCNU in breast carcinoma.

    abstract::The Eastern Cooperative Oncology Group undertook a limited institution phase II study of PCNU in advanced, metastatic breast cancer. The study was limited to patients treated with 1 to 2 prior chemotherapy regimens. Accrual goals were 30 patients but the study was terminated after 10 patients had no response, with a r...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00170866

    authors: Rubins JM,Taylor SG 4th

    更新日期:1989-07-01 00:00:00

  • Capecitabine: preclinical pharmacology studies.

    abstract::Capecitabine (N4-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine) is a novel fluoropyrimidine carbamate, which was designed to be sequentially converted to 5-fluorouracil (5-FU) by three enzymes located in the liver and in tumors; the final step is the conversion of 5'-deoxy-5-fluorouridine (5'-DFUR) to 5-FU by thymidine ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,评审

    doi:10.1023/a:1006497231579

    authors: Ishitsuka H

    更新日期:2000-11-01 00:00:00

  • Effects of diflubenzuron and clanfenur on mouse bone marrow cells.

    abstract::Diflubenzuron (DFB) and Clanfenur (CFN) belong to a group of compounds called Benzoylphenyl Ureas (BPUs). Several BPUs regulate cell growth in insects and/or inhibit growth of B-16 murine melanomas. In view of potential clinical use for these compounds, DFB and CFN were selected as examples of BPUs and tested for effe...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00874426

    authors: Jenkins VK,Juneja HS,Ives K,Lee S,Perry RR

    更新日期:1993-11-01 00:00:00

  • Proteasome inhibition and mechanism of resistance to a synthetic, library-based hexapeptide.

    abstract::Background The hexapeptide 4A6 (Ac-Thr(tBu)-His(Bzl)-Thr(Bzl)-Nle-Glu(OtBu)-Gly-Bza) was isolated from a peptide library constructed to identify peptide-based transport inhibitors of multidrug resistance (MDR) efflux pumps including P-glycoprotein and Multidrug Resistance-associated Protein 1. 4A6 proved to be a subst...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-018-0569-x

    authors: Oerlemans R,Berkers CR,Assaraf YG,Scheffer GL,Peters GJ,Verbrugge SE,Cloos J,Slootstra J,Meloen RH,Shoemaker RH,Dijkmans BAC,Scheper RJ,Ovaa H,Jansen G

    更新日期:2018-10-01 00:00:00

  • A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in phase I clinical trial pharmacokinetics.

    abstract::We have developed a specific and sensitive method aiming at docetaxel (Taxotere) determination in plasma of treated patients. This involved solid-phase extraction of 1 ml of plasma onto carboxylic acid (CBA) grafted silica cartridges followed by reversed-phase liquid chromatography with UV detection. The best selectiv...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1023/a:1006327302041

    authors: Ardiet CJ,Tranchand B,Zanetta S,Guillot A,Bernard E,Peguy M,Rebattu P,Droz JP

    更新日期:1999-01-01 00:00:00

  • First-in-human phase I dose escalation study of MK-8033 in patients with advanced solid tumors.

    abstract::Background C-Met, which is frequently activated in multiple cancers, has been implicated in tumor formation, progression, metastasis, angiogenesis, and resistance to multiple therapies. MK-8033 is a small-molecule inhibitor of c-Met that binds preferentially to the activated conformation, and has demonstrated anti-tum...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-018-0567-z

    authors: Keedy VL,Lenz HJ,Saltz L,Whisenant JG,Berlin JD,Camacho LH

    更新日期:2018-10-01 00:00:00

  • The nuclear transport capacity of a human-pancreatic ribonuclease variant is critical for its cytotoxicity.

    abstract::We have previously described a human pancreatic-ribonuclease variant, named PE5, which carries a non-contiguous extended bipartite nuclear localization signal. This signal comprises residues from at least three regions of the protein. We postulated that the introduction of this signal in the ribonuclease provides it w...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-010-9426-2

    authors: Tubert P,Rodríguez M,Ribó M,Benito A,Vilanova M

    更新日期:2011-10-01 00:00:00

  • Phase I study of matuzumab in combination with 5-fluorouracil, leucovorin and cisplatin (PLF) in patients with advanced gastric and esophagogastric adenocarcinomas.

    abstract:BACKGROUND:To evaluate the safety and tolerability of two different weekly doses of the fully humanized epidermal growth factor receptor (EGFR)-targeting monoclonal antibody matuzumab combined with high-dose 5-fluorouracil, leucovorin and cisplatin (PLF) in the first-line treatment of patients with EGFR-positive advanc...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-012-9848-0

    authors: Trarbach T,Przyborek M,Schleucher N,Heeger S,Lüpfert C,Vanhoefer U

    更新日期:2013-06-01 00:00:00

  • Phase II trial of intravenous melphalan for metastatic colorectal carcinoma. A Southwest Oncology Group study.

    abstract::Based on the high response rates seen among patients with colon cancer receiving high dose Melphalan with autologous marrow infusion, the Southwest Oncology Group conducted a Phase II trial of the compound at a conventional dose. The initial starting dose of 40 mg/m2 was reduced to 30 mg/m2 after severe myelotoxicity ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/BF00171991

    authors: Knight WA 3rd,Goodman P,Taylor SA,Macdonald JS,Coltman CA Jr,Constanzi JJ,Baker LH

    更新日期:1990-01-01 00:00:00

  • Synthesis, characterization, and evaluation of Cd[L-proline]2, a novel histone deacetylase inhibitor that induces epigenetic modification of histone deacetylase isoforms in A549 cells.

    abstract::Histone deacetylases (HDACs) play an important role in the epigenetic regulation of gene expression through their effects on the compact chromatin structure. In clinical studies, several classes of histone deacetylase inhibitors (HDACi) have demonstrated potent anticancer activities with metal complexes. Hence, we syn...

    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-017-0489-1

    authors: Chidambaram A,Sekar A,S H K,Chidambaram RK,Arunachalam K,G P S,Vilwanathan R

    更新日期:2017-12-01 00:00:00