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

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

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.

Eligibility 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