Status:
TERMINATED
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-...
Detailed Description
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 saf...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00087048
Start Date
April 1 2004
End Date
February 1 2006
Last Update
March 22 2016
Active Locations (2)
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1
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065