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Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine objective response rate in both previously treated and untreated patients.

Safety Issue:

Yes

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067626

NCT ID:

NCT00005037

Start Date:

January 2000

Completion Date:

April 2008

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Waukesha Memorial HospitalWaukesha, Wisconsin  53188