Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

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

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Topotecan; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed lung cancer

• All histologic types eligible

• Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) ≤ 2

• Karnofsky PS ≥ 60%

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Total bilirubin ≤ 1.5 mg/dL

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other active invasive malignancy

• No uncontrolled illness including, but not limited to:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• No psychiatric illness/social situation that would limit compliance with study requirements

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

• No prior therapy with topotecan or vinorelbine ditartrate

• No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)

• Recovered from agents administered > 4 weeks earlier

• No other concurrent investigational agents

• No concurrent palliative radiotherapy

• No other concurrent anticancer therapies or agents

• No concurrent hormones or other chemotherapy except for the following:

• Steroids for adrenal failure

• Hormones for nondisease-related conditions (e.g., insulin for diabetes)

• Intermittent dexamethasone as an antiemetic