Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer (SCLC)

• Recurrent extensive stage disease

• No mixed histology

• Measurable disease

• At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI

• Sensitive disease

• Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)

• Eligible for high-dose chemotherapy

• No symptomatic brain metastases affecting performance status

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• At least 2 months

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• Hematocrit > 35% (without transfusion)

Hepatic

• Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal*

• Alkaline phosphatase ≤ 2 times normal*

• Bilirubin ≤ 2.0 mg/dL

• Albumin > 2.5 g/dL

• Hepatitis B surface antigen negative

• No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present

Renal

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• No history of cardiac arrhythmias

• No congestive heart failure

• No ischemic heart disease

• No stroke or other embolic disease requiring daily treatment that would preclude study participation

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• HIV negative

• No known seizure disorder

• No active infection requiring systemic therapy within the past 2 weeks

• No known hypersensitivity to topotecan hydrochloride

• No medical or psychiatric condition that would preclude study participation

• No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy

• No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC

• No prior topotecan hydrochloride

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior investigational agent

• No other concurrent investigational agent