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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00025285
First Posted: January 27, 2003
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


Further study details as provided by Wake Forest University Health Sciences:

Enrollment: 46
Actual Study Start Date: November 2001
Study Completion Date: September 29, 2004
Primary Completion Date: September 29, 2004 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025285


Locations
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
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 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
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00025285     History of Changes
Other Study ID Numbers: REBACDR0000068946
CCCWFU-62400
NCI-5293
First Submitted: October 11, 2001
First Posted: January 27, 2003
Last Update Posted: April 19, 2017
Last Verified: August 2009

Keywords provided by Wake Forest University Health Sciences:
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Carboplatin
Thalidomide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors