Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CCCWFU-62400 NCI-5293, NCT00025285, 5293

Objectives

1. 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.
2. Determine the progression-free and overall survival of patients treated with this regimen.
3. Evaluate the toxicity profile of this regimen in these patients.

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

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

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

Expected Enrollment

A total of 39-70 patients will be accrued for this study within 14 months.

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Antonius Miller, MD, Protocol chair		Ph: 336-713-4392; 800-446-2255
James Atkins, MD, Protocol co-chair		Ph: 919-580-0000 Email: jatkins@cancersmoc.com

Registry Information
Official Title		Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients with Advanced Non-Small Cell Lung Cancer
Trial Start Date		2001-11-08
Registered in ClinicalTrials.gov		NCT00025285
Date Submitted to PDQ		2001-08-07
Information Last Verified		2004-11-30
NCI Grant/Contract Number		CA12197, CA81851

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