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.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer Squamous Cell Lung Cancer recurrent non-small cell lung cancer Adenocarcinoma of the Lung Quality of Life large cell lung cancer	Drug: temozolomide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Afshin Dowlati,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000068336; CWRU-SCH-1500; NCI-G00-1876; CWRU-050002; SPRI-P00349
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006877
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08