RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combining topotecan and paclitaxel with that of combining etoposide and cisplatin in treating patients who have extensive-stage small cell lung cancer.

Condition	Treatment or Intervention	Phase
extensive stage small cell lung cancer Recurrent Small Cell Lung Cancer	Drug: cisplatin  Drug: etoposide  Drug: filgrastim  Drug: paclitaxel  Drug: topotecan	Phase II

Further Study Details: 

OBJECTIVES: I. Compare the response rates in patients with extensive stage small cell lung cancer treated with topotecan and paclitaxel versus etoposide and cisplatin. II. Compare time to response, response duration, time to progression, and survival in these patients treated with these regimens. III. Determine the toxicity profiles of these regimens in these patients. IV. Compare the effects of these regimens on symptoms of disease in these patients.

PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to gender, ECOG performance status (0-1 vs 2), and elevated LDH (absent vs present). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Arm II: Patients receive cisplatin IV over 3 hours on day 1 and etoposide IV over 30 minutes on days 1-3. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of extensive stage small cell lung cancer
• At least 1 bidimensionally measurable non CNS lesion; At least 1 cm in one diameter and at least 2 cm in another diameter by CT or MRI scan; At least 2 cm in two diameters by x-ray, ultrasound, or for palpable tumor masses by physical exam; Measurable skin lesion at least 1 cm in at least one diameter by photography
• No symptomatic CNS and/or leptomeningeal metastases requiring corticosteroid therapy to control symptoms

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: At least 24 hours since prior radiotherapy if no marked bone marrow suppression expected; At least 6 weeks since prior radiotherapy to measurable lesion if evidence of progression; Concurrent radiotherapy for bone pain control allowed
• Surgery: At least 3 weeks since prior surgery
• Other: At least 30 days or 5 half lives (whichever is longer) since prior investigational drug; No other concurrent investigational drugs

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 3 months
• Hematopoietic: WBC at least 3,500/mm3; Hemoglobin at least 9.0 g/dL; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT, SGPT, and alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No preexisting cardiac disease; No congestive heart failure; No cardiac arrhythmia requiring therapy; No myocardial infarction within the past 3 months
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 3 months before, during, and for at least 4 weeks after study; No active uncontrolled infection; No other concurrent or prior malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer; No other severe medical problem or any other medical condition that would preclude study

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Nathan Levitan,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000068248; CWRU-SKF-2598; NCI-G00-1864; CWRU-059916; SB-SKF-104864/RSD-1010P3/4
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006374
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08