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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: karenitecin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: karenitecin<br>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. | Drug: karenitecin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer