Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if docetaxel is more effective with or without oblimersen in treating non-small cell lung cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated.

Detailed Description
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OBJECTIVES: Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen (G3139). Compare the proportion of major antitumor responses in patients treated with these regimens. Compare the response duration and time to progression in patients treated with these regimens. Compare the safety and clinical benefit of these regimens, in terms of changes in performance status and tumor-related symptoms, in these patients. Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to response to prior first-line chemotherapy regimen (progression vs stable disease, partial response, or complete response), ECOG performance status (0-1 vs 2), and prior paclitaxel treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oblimersen (G3139) IV continuously on days 1-7 and docetaxel IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease upon completion of 8 courses may receive 8 or more additional courses at physician's discretion. Arm II: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Upon completion of 8 courses, patients may continue to receive docetaxel off study at physician's discretion. Patients are followed every 9 weeks for up to 18 months. PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.

Official Title
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Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: oblimersen sodium
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of non-small lung cancer (NSCLC) Stage IIIB (malignant pleural/pericardial effusion) or IV Relapsed or refractory disease Measurable disease that has not been irradiated Previously treated with 1, and only 1, cytotoxic chemotherapy regimen in the neoadjuvant, adjuvant, or metastatic setting No untreated or symptomatic brain metastases or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 (without growth factor support) Platelet count at least 100,000/mm^3 No bleeding or coagulation disorder Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Albumin at least 3.0 g/dL PT no greater than 1.5 times ULN OR INR no greater than 1.3 PTT no greater than 1.5 times ULN No chronic hepatitis No chronic cirrhosis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled congestive heart failure Pulmonary: No severe pulmonary disease No requirement for oxygen due to pneumonectomy No severe pleural effusion secondary to NSCLC Immunologic: HIV negative No active infection No active autoimmune disease Other: No other concurrent active cancer No uncontrolled diabetes mellitus No uncontrolled seizure disorder No peripheral neuropathy grade 2 or greater No active peptic ulcer disease No other significant medical disease No intellectual, emotional, or physical disability that would preclude study participation No neurologic disorders, overt psychosis, mental disability, or evidence of a limited capacity to give informed consent or to comply with study treatment No known hypersensitivity to phosphorothioate-containing oligonucleotides No history of hypersensitivity to drugs containing the excipient Tween 80 (polysorbate 80) Satisfactory venous access for multi-day continuous infusion Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior cytokines or vaccine therapy for NSCLC At least 3 weeks since prior immunotherapy or biologic therapy for NSCLC No concurrent anticancer biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for NSCLC No prior docetaxel No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent corticosteroids* except for the following conditions: CNS disease Underlying lung disease NOTE: *Dose must be stable or decreasing for at least 4 weeks before study participation Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for NSCLC No prior radiotherapy to 25% or more of bone marrow (e.g., whole pelvis) No concurrent anticancer radiotherapy Surgery: At least 3 weeks since prior surgery for NSCLC No prior organ allograft Other: Recovered from prior therapy Prior first-line epidermal growth factor receptors (EGFR) administered with cytotoxic therapy are allowed At least 3 weeks since prior investigational drugs At least 3 weeks since other prior therapy NSCLC No prior anticancer therapy subsequent to the first (and only) prior cytotoxic chemotherapy regimen No prior second-line EGFR therapy No prior oblimersen (G3139) No other concurrent investigational or anticancer therapies No concurrent anticoagulation therapy except for warfarin (1 mg/day) for central line prophylaxis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: oblimersen sodium|nan|
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer