Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Oblimersen

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed extensive stage small cell lungcancer

• No active CNS disease

• CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 2 months

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal (ULN)

• PT and PTT no greater than 1.5 times ULN

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergic reactions to compounds of similar chemical or biologic composition to study agents

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• See Disease Characteristics

• At least 1 week since prior CNS radiotherapy and recovered

• No prior radiotherapy to more than 25% of skeleton

• No other prior anticancer therapy

• No other concurrent investigational agents

• No other concurrent anticancer therapy

• No concurrent anticoagulation therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients