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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
  Purpose

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.


Condition Intervention Phase
Lung Cancer Drug: temozolomide Drug: Temozolomide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • response rate in both previously treated and untreated patients.

Secondary Outcome Measures:
  • freedom from progression (FFP) median, 1-year and 2-year survival rates in both groups.

Enrollment: 51
Study Start Date: January 2000
Study Completion Date: April 2008
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide
Temozolomide capsule once a day for 42 days every 10 weeks.
Drug: temozolomide Drug: Temozolomide
Temozolomide capsule once a day for 42 days every 10 weeks.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005037


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00005037     History of Changes
Other Study ID Numbers: CDR0000067626
P30CA006927 ( U.S. NIH Grant/Contract )
FCCC-99032
NCI-G00-1712
First Submitted: April 6, 2000
First Posted: March 16, 2004
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Fox Chase Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents