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Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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 CarolinaSpartanburg, South Carolina  29303
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - GreenvilleGreenville, South Carolina  29615
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534