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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00005037
First received: April 6, 2000
Last updated: May 5, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • freedom from progression (FFP) median, 1-year and 2-year survival rates in both groups. [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00005037     History of Changes
Other Study ID Numbers: CDR0000067626, P30CA006927, FCCC-99032, NCI-G00-1712
Study First Received: April 6, 2000
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014