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

OBJECTIVES:

• Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy.
• Determine the effect of prior response to chemotherapy on response to this drug in these patients.
• Determine survival and failure-free survival of patients treated with this drug.
• Determine the toxicity profile of this drug in these patients.

OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory).

Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.

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