Trial | NCT00025285  Report issue

Title

Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    46
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.
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 Started
Nov 01
2001
Primary Completion
Sep 29
2004
Study Completion
Sep 29
2004
Last Update
Sep 09
2021

Drug carboplatin

Drug irinotecan hydrochloride

Drug thalidomide

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
No Results Posted