Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2002
Last updated: December 26, 2009
Last verified: August 2003

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: etoposide
Drug: exisulind
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
Detailed Description:


  • Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin, etoposide, and exisulind.
  • Determine the response rate of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 4 months for 2 years.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 8 months.


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


  • Histologically or cytologically confirmed small cell lung cancer
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Lesions considered nonmeasurable include:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • Must not be considered for combined chemotherapy and radiotherapy
  • No active CNS metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST no greater than 2 times ULN
  • No clinically significant hepatic disease


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No clinically significant renal disease


  • No clinically significant cardiac disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No concurrent uncontrolled illness
  • No known sensitivity to sulindac


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy for small cell lung cancer
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal agents except:

    • Steroids for adrenal failure
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy, including for palliation
  • No concurrent radiotherapy


  • Not specified


  • More than 7 days since prior sulindac
  • No concurrent sulindac
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00041054

  Show 83 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Study Chair: Ramaswamy Govindan, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Wang XF, Govindan R, Herndon JE, et al.: A phase II study of carboplatin, etoposide and exisulind in patients with extensive stage small cell lung cancer: CALGB 30104. [Abstract] J Clin Oncol 23 (Suppl 16): A-7161, 660s, 2005. Identifier: NCT00041054     History of Changes
Other Study ID Numbers: CDR0000069439, CLB-30104
Study First Received: July 8, 2002
Last Updated: December 26, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Sulindac sulfone
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents processed this record on July 01, 2015