Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Antonius A. Miller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000068946
NCT ID:
NCT00025285
Start Date:
November 2001
Completion Date:
Related Keywords:
- Lung Cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- adenosquamous cell lung cancer
- bronchoalveolar cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
