Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer
A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)
연구 개요
상세 설명
Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation and/or apoptosis. Pivanex has been well tolerated in clinical trials and has shown preliminary evidence of efficacy in patients with non-small cell lung cancer. Docetaxel is an approved drug for second-line treatment of non-small cell lung cancer. Preclinical studies indicate that the combination of Pivanex and docetaxel is synergistic.
Purpose: This open-label randomized trial will evaluate whether combination therapy with Pivanex and docetaxel provides clinical benefit over docetaxel alone in patients with chemotherapy resistant non-small cell lung cancer.
Objectives:
- Compare the survival of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone
- Compare the time to disease progression, tumor responses, and safety profile of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone
Outline: This is a randomized, open-label, multicenter study in patients with non-small cell lung cancer who have previously been treated with no more than one prior platinum containing chemotherapy regimen. Patients are stratified by ECOG performance status (0-1 vs. 2), response to prior platinum based chemotherapy (progression vs. CR/PR/SD) and prior taxane therapy (yes vs. no). Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive the combination of Pivanex intravenously on Days 1-3 and docetaxel intravenously on Day 4. Treatment repeats every 21 days until disease progression or treatment withdrawal.
- Arm B: Patients receive docetaxel intravenously on Day 1. Treatment repeats every 21 days until disease progression or treatment withdrawal.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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La Verne, California, 미국, 91750
- Wilshire Oncology Medical Group
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Louisiana
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New Orleans, Louisiana, 미국, 70115
- Hematology And Oncology Specialists, Llc
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New York
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Bronx, New York, 미국, 10467
- Montefiore Medical Center, Department of Oncology
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Brooklyn, New York, 미국, 11235
- HemOnCare
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North Carolina
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Gastonia, North Carolina, 미국, 28054
- Gaston Hematology & Oncology Associates
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Edinburgh, 영국, EH4 2XU
- University of Edinburgh, Edinburgh Cancer Centre
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New Delhi, 인도, 110 085
- Rajiv Gandhi Cancer Institute & Research Center
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Thiruvananthapuram, 인도, 695 011
- Regional Cancer Centre
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연구 대상 성별
설명
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Treatment with one prior platinum-based chemotherapy regimen (Eligible patients may include:
- Patients previously treated with adjuvant or neoadjuvant chemotherapy (must be completed within 6 months prior to randomization) or
- Patients who have received chemotherapy for advanced or metastatic lung cancer);
- Recurrent or progressive NSCLC (local, distant, or both) following initial chemotherapy);
- Measurable or non-measurable disease;
- Males and females, age => 18 years;
- Adequate renal function with creatinine => 1.5 mg/dl;
- Adequate liver function with alkaline phosphatase => 2.5 X upper limit of normal, SGOT, and SGPT => 1.5 X upper limit of normal; and total bilirubin => upper limit of normal;
- Adequate bone marrow function: platelets > 100,000/mm3, hemoglobin => 9 g/dL, and absolute neutrophil count (ANC) => 1,500 cells/mm3;
- Able to give informed consent;
- Discontinuation of previous surgery, radiation therapy or cancer chemotherapy at least four weeks prior to randomization (six weeks if a prior nitrosourea or mitomycin C), with recovery from treatment-associated toxicity;
- A predicted life expectancy of at least 12 weeks; and
- ECOG performance status of 0, 1, or 2.
Exclusion Criteria:
- Receipt of more than one chemotherapy regimen for NSCLC;
- A second malignancy within the last 5 years other than curatively treated carcinoma-in-situ or non-melanoma skin cancer;
- Pregnant or lactating females (Females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control);
- Known HIV-positive patients;
- Acute medical problems, such as ischemic heart or lung disease or uncontrolled systemic infection;
- Patients with any underlying medical conditions or circumstance, which would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
- Patients receiving investigational agents within 30 days of the screening visit;
- Known allergy to reagents in the study;
- Prior docetaxel therapy;
- Symptomatic or untreated brain metastases (Patients with brain metastases are eligible if they are clinically and neurologically stable for > 4 weeks since therapy (radiation therapy, radiosurgery/gamma knife; surgical resection) as determined by the investigator and either off corticosteroids or on a stable dose of corticosteroids).
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TTP-200-03-01
- NSCLC Clincal Trial
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