Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2004-01-01
• 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 temozolomide in treating patients who have relapsed or progressive small cell lung cancer.

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

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed relapsed or progressive small cell lung cancer

• Classical or intermediate variant OR

• Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin

• Bidimensionally measurable disease

• At least 1 cm by 1 cm by physical exam or radiologic exam

• Outside prior radiation port unless clinical evidence of disease progression

• Previously radiated brain metastases allowed provided stable or improved

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present)

• Alkaline phosphatase no greater than 5 times ULN

Renal:

• Creatinine no greater than 2 mg/dL

Other:

• HIV negative

• No AIDS-related illness

• No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction)

• No active nonmalignant systemic disease that would preclude study

• No other active invasive malignancy within the past year or concurrently requiring ongoing treatment

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy

• No concurrent immunotherapy

• No concurrent biologic therapy

• Concurrent epoetin alfa allowed

Chemotherapy:

• At least 4 weeks since prior chemotherapy

• No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease

• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone)

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy to 15% or more of bone marrow

• At least 1 week since prior radiotherapy to less than 15% of bone marrow

• No prior radiotherapy to 50% or more of bone marrow

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• Recovered from prior therapy

• No other concurrent investigational drugs

• Concurrent pamidronate allowed