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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells and be an effective treatment for stage IIIB or stage IV non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Determine the response rate and duration of response in patients with stage IIIB or IV non-small cell lung cancer treated with carboplatin, irinotecan, and thalidomide. - Determine the progression-free and overall survival of patients treated with this regimen. - Evaluate the toxicity profile of this regimen in these patients. OUTLINE: Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease receive up to 6 courses of therapy. Patients also receive oral thalidomide once daily beginning on day 1 and continuing until disease progression. Patients are followed every 3 months until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 39-70 patients will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage IIIB (malignant pleural effusion) or stage IV non-small cell lung cancer - Squamous cell carcinoma - Basaloid carcinoma - Adenocarcinoma - Bronchoalveolar carcinoma - Adenosquamous carcinoma - Large cell carcinoma - Large cell neuroendocrine carcinoma - Giant cell carcinoma - Sarcomatoid carcinoma - Non-small cell carcinoma not otherwise specified - Measurable disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - The following lesions are considered nonmeasurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural or pericardial effusions - Abdominal masses unconfirmed by imaging techniques - Cystic lesions - Previously irradiated brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 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 1.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective contraception 4 weeks prior to, during, and for at least 4 weeks after thalidomide - No prior seizures - No other concurrent or prior malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix - No other serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes) or intermittent dexamethasone as an antiemetic Radiotherapy: - Prior radiotherapy for brain metastasis allowed if neurologically stable and off steroids - No concurrent palliative radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoniusMiller, Study Chair, Comprehensive Cancer Center of Wake Forest University
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina *Recruiting*
Greenville, North Carolina, 27858-4354
United States
Recruiting Ron Allison 252-744-2900
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Antonius Miller 336-713-4392
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Southeastern Medical Oncology Center *Recruiting*
Goldsboro, North Carolina, 27534
United States
Recruiting James Atkins 919-580-0000
Additional Information:
Study ID Numbers: CDR0000068946; CCCWFU-62400,NCI-5293
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025285
Other Non-Small Cell Lung Cancer Studies:
1. Phase 1-2a Study of TLK286 in Combination with Cisplatin for Locally Advanced or Metastatic NSCLC
2. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
3. Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy
4. Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer
5. Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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