Clinical trial NCT00006877: Temozolomide in Treating Patients With Metastatic Non-small Cell Lung Cancer
Official title: A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Schering-Plough
First posted: 2004-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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 metastatic non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Determine the efficacy of temozolomide in terms of complete and partial response rates in patients with metastatic non-small cell lung cancer. II. Determine the safety of this regimen in these patients. III. Determine the time to progression and overall survival in patients treated with this regimen. IV. Determine the quality of life and changes in disease-related symptoms in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment continues every 4 weeks for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks during study, and then every 8 weeks after study. Patients are followed for 1 month and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 15-60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven metastatic non-small cell lung cancer Eligible subtypes: Adenocarcinoma Squamous cell carcinoma Large cell carcinoma At least 1 bidimensionally measurable lesion, at least 2 cm by 2 cm in perpendicular diameter on radiologic study Previously irradiated bony lesions are not considered measurable unless there is evidence of disease progression at that site prior to study No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (5 times ULN if documented liver metastases) Alkaline phosphatase no greater than 2 times ULN (5 times ULN if documented liver metastases) Renal: Blood urea nitrogen no greater than 1.5 times ULN Creatinine no greater than 1.5 times ULN Other: No active nonmalignant systemic disease that would increase risk No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy or biologic therapy No concurrent growth factors or epoetin alfa Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for local control or as palliative therapy for a painful bony lesion allowed No prior radiotherapy to 50% or more of bone marrow At least 4 weeks since prior radiotherapy to 15% or more of bone marrow (2 weeks for radiotherapy to less than 15% of bone marrow) and recovered No concurrent radiotherapy Surgery: Not specified Other: Recovered from any prior therapy No other concurrent investigational drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Afshin Dowlati, MD
role: STUDY_CHAIR
References: