Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2006-01-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-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: Camptothecin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (NSCLC)

• Squamous cell carcinoma

• Basaloid carcinoma

• Adenocarcinoma

• Bronchoalveolar carcinoma

• Adenosquamous cell carcinoma

• Large cell carcinoma

• Large cell neuroendocrine carcinoma

• Giant cell carcinoma

• Sarcomatoid carcinoma

• Non-small cell carcinoma not otherwise specified

• Histologic or cytologic documentation of recurrence required if disease previously completely resected

• Must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for NSCLC

• At least 1 unidimensionally measurable lesion

• At least 20 mm with conventional techniques OR

• At least 10 mm with spiral CT scan

• Lesions that are not considered measurable include the following:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Tumor lesions in a previously irradiated area

• Controlled CNS metastases allowed if patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than upper limit of normal

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)

• No prior irinotecan or other camptothecin drug

• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• No concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes)

• No concurrent steroids except for adrenal failure

Radiotherapy:

• See Disease Characteristics

• Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present

• At least 4 weeks since prior radiotherapy

• No concurrent palliative radiotherapy

Surgery:

• See Disease Characteristics