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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00025285

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

34.9

Actual Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: irinotecan hydrochloride Drug: thalidomide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Sep 29, 2004

Actual Study Completion Date :

Sep 29, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Central Illinois	Decatur	Illinois	United States	62526
2	Southeastern Medical Oncology Center	Goldsboro	North Carolina	United States	27534-9479
3	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
4	CCOP - Greenville	Greenville	South Carolina	United States	29615
5	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303

Sponsors and Collaborators

Wake Forest University Health Sciences
National Cancer Institute (NCI)

Investigators

Principal Investigator: Antonius A. Miller, MD, Wake Forest University Health Sciences
Principal Investigator: James N. Atkins, MD, Southeastern Medical Oncology Center - Goldsboro