Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• 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 nitrocamptothecin in treating patients who have advanced small cell lung cancer.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Rubitecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen

• Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR

• Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy

• Minimum of 1 target lesion that can be accurately measured in at least 1 dimension

• 20 mm or more with conventional techniques OR

• 10 mm or more with spiral CT scans

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Neutrophil count at least 2,000/mm^3

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

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)

Renal:

• Creatinine no greater than 1.7 mg/dL

Cardiovascular:

• No ischemic heart disease within the past 6 months

• Normal 12 lead electrocardiogram

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer

• No unstable systemic disease or active uncontrolled infection

• No psychological, familial, sociological, or geographical condition that may preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior maintenance therapy with biologic agents following first line chemotherapy allowed

• No concurrent filgrastim (G-CSF) with nitrocamptothecin

Chemotherapy:

• See Disease Characteristics

• Greater than 4 weeks since prior chemotherapy

• No more than 1 prior chemotherapy regimen for extensive disease

• Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• Greater than 4 weeks since prior radiotherapy

Surgery:

• Greater than 2 weeks since prior major surgery

Other:

• No other concurrent anticancer therapy

• No other concurrent investigational therapy