Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)

• Histologically or cytologically confirmed recurrent or refractory small cell lung cancer

• Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)

• No mixed histology

• Measurable or evaluable disease that has not been in the field of prior radiotherapy

• No uncontrolled CNS metastases (treated CNS metastases eligible)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

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

Hepatic:

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

• Direct bilirubin normal

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No unstable angina pectoris

• No uncontrolled congestive heart failure

• No myocardial infarction within the past 3 months

Other:

• No uncontrolled infections

• No other concurrent malignancy except skin cancer or localized prostate cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)

• At least 3 months since other prior chemotherapy

Radiotherapy:

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• At least 3 weeks since any prior major surgery