Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry GENTA-GN304 NCI-G01-2046, UCLA-0301058, NCT00030641

Objectives

1. Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen (G3139).
2. Compare the proportion of major antitumor responses in patients treated with these regimens.
3. Compare the response duration and time to progression in patients treated with these regimens.
4. Compare the safety and clinical benefit of these regimens, in terms of changes in performance status and tumor-related symptoms, in these patients.
5. Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens.

Entry Criteria

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

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

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/mm³ (without growth factor support)
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 280 patients (140 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Genta Incorporated

Deborah Braccia, Protocol chair		Ph: 908-286-9800

Registry Information
Official Title		Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients with Previously Treated Non-Small Cell Lung Cancer
Trial Start Date		2001-10-23
Registered in ClinicalTrials.gov		NCT00030641
Date Submitted to PDQ		2001-12-13
Information Last Verified		2003-09-04
NCI Grant/Contract Number		CA08748