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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: etoposide; Drug: carboplatin; Drug: exisulind

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00041054

CALGB-30104

CDR0000069439 (Registry Identifier)

CLB-30104

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

• No clinically significant cardiac disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• 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

Radiotherapy:

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

Surgery:

• Not specified

Other:

• More than 7 days since prior sulindac
• No concurrent sulindac

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

carboplatin + etoposide + exisulind

Experimental group

Description:

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.

Treatment:

Drug: etoposide

Drug: exisulind

Drug: carboplatin