The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
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.
Inclusion 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-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
- 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
- SGOT and 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Afshin Dowlati, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000372872
NCT ID:
NCT00087048
Start Date:
April 2004
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
