- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005037
Temozolomide in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer
Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients
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 stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the objective response rate to temozolomide in previously treated (closed to accrual 8/01) and chemotherapy-naive patients with advanced non-small cell lung cancer. II. Determine the freedom from progression median, and 1-year and 2-year survival rates in these patients on this regimen.
OUTLINE: Patients are stratified by prior chemotherapy (yes (closed to accrual 8/01) vs no). Patients receive oral temozolomide daily for 42 days. Treatment repeats every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months.
PROJECTED ACCRUAL: Up to 66 patients (33 per stratum (previously treated stratum closed to accrual 8/01)) will be accrued for this study within 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Wisconsin
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Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Stage IIIB, IV, or recurrent non-small cell lung cancer for which no curative therapy with surgery, radiation, or combination chemoradiotherapy exists Chemotherapy-naive patients: No prior chemotherapy OR At least 6 months since prior adjuvant, induction, or radiosensitizing chemotherapy OR Previously treated patients (closed to accrual 8/01): No more than one prior chemotherapy regimen for relapsed or metastatic disease AND/OR No more than one prior adjuvant, induction, or radiosensitizing chemotherapy within the past 6 months Measurable or evaluable disease CNS metastases allowed (previously treated metastases cannot be only site of measurable disease) No brain metastases with prior whole body irradiation
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other active invasive malignancies
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy Surgery: See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Temozolomide
Temozolomide capsule once a day for 42 days every 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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response rate in both previously treated and untreated patients.
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Secondary Outcome Measures
Outcome Measure |
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freedom from progression (FFP) median, 1-year and 2-year survival rates in both groups.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Corey J. Langer, MD, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067626
- P30CA006927 (U.S. NIH Grant/Contract)
- FCCC-99032
- NCI-G00-1712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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