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

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00025285

Purpose

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	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: irinotecan hydrochloride Drug: thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Thalidomide Carboplatin Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date:

November 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025285

Locations

United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534-9479
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068946, CCCWFU-62400, NCI-5293
Study First Received:	October 11, 2001
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00025285 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Anti-Bacterial Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Angiogenesis Inhibitors
Camptothecin
Pharmacologic Actions
Carcinoma
Neoplasms
Lung Diseases
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009