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Randomized Study of Docetaxel Versus Docetaxel Plus Genasenseā„¢ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer

Phase 2/Phase 3
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Randomized Study of Docetaxel Versus Docetaxel Plus Genasenseā„¢ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer


- 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

- Compare the response duration and time to progression in patients treated with these

- 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

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

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- 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


- 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


- Creatinine no greater than 1.5 times ULN


- No New York Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure


- No severe pulmonary disease

- No requirement for oxygen due to pneumonectomy

- No severe pleural effusion secondary to NSCLC


- HIV negative

- No active infection

- No active autoimmune disease


- 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

- 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


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


- 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


- 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


- At least 3 weeks since prior surgery for NSCLC

- No prior organ allograft


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Deborah Braccia

Investigator Role:

Study Chair

Investigator Affiliation:

Genta Incorporated


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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