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

NCT ID: NCT00025285

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-01
• Study Completion Date: 2004-09-29

Brief Summary

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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

thalidomide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonius A. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

James N. Atkins, MD

Role: PRINCIPAL_INVESTIGATOR

Southeastern Medical Oncology Center - Goldsboro

Locations

CCOP - Central Illinois

Decatur, Illinois, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-62400

Identifier Type: -

Identifier Source: secondary_id

NCI-5293

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000068946

Identifier Type: -

Identifier Source: org_study_id