Expired Study
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Detroit, Michigan 48202


Purpose:

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.


Study summary:

OBJECTIVES: Primary - Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride. Secondary - Determine the safety and toxic effects of this drug in these patients. - Determine the recurrence-free survival of patients treated with this drug. - Determine time to response and tumor response in patients treated with this drug. - Determine the quality of life of patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter. Patients are followed at 7-14 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed small cell lung cancer (SCLC) - Recurrent extensive stage disease - No mixed histology - Measurable disease - At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI - Sensitive disease - Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy) - Eligible for high-dose chemotherapy - No symptomatic brain metastases affecting performance status PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy - At least 2 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL - Hematocrit > 35% (without transfusion) Hepatic - Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal* - Alkaline phosphatase ≤ 2 times normal* - Bilirubin ≤ 2.0 mg/dL - Albumin > 2.5 g/dL - Hepatitis B surface antigen negative - No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present Renal - Creatinine clearance ≥ 40 mL/min Cardiovascular - No history of cardiac arrhythmias - No congestive heart failure - No ischemic heart disease - No stroke or other embolic disease requiring daily treatment that would preclude study participation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - HIV negative - No known seizure disorder - No active infection requiring systemic therapy within the past 2 weeks - No known hypersensitivity to topotecan hydrochloride - No medical or psychiatric condition that would preclude study participation - No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy - No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC - No prior topotecan hydrochloride Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 2 months since prior investigational agent - No other concurrent investigational agent


NCT ID:

NCT00087048


Primary Contact:

Study Chair
Afshin Dowlati, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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