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Temozolomide in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005037
First Posted: March 16, 2004
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
April 6, 2000
March 16, 2004
May 6, 2014
January 2000
October 2002   (Final data collection date for primary outcome measure)
response rate in both previously treated and untreated patients.
Not Provided
Complete list of historical versions of study NCT00005037 on ClinicalTrials.gov Archive Site
freedom from progression (FFP) median, 1-year and 2-year survival rates in both groups.
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: temozolomide
  • Drug: Temozolomide
    Temozolomide capsule once a day for 42 days every 10 weeks.
Experimental: Temozolomide
Temozolomide capsule once a day for 42 days every 10 weeks.
Interventions:
  • Drug: temozolomide
  • Drug: Temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2008
October 2002   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005037
CDR0000067626
P30CA006927 ( U.S. NIH Grant/Contract )
FCCC-99032
NCI-G00-1712
Not Provided
Not Provided
Not Provided
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
Fox Chase Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP