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CompletedPhase 2NCT00041054
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and etoposide

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?83 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: etoposide; Drug: exisulind
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
  • Cedars-Sinai Medical CenterLos Angeles, California
  • Veterans Affairs Medical Center - San DiegoSan Diego, California
  • UCSF Comprehensive Cancer CenterSan Francisco, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • Lombardi Cancer CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
  • Broward General Medical CenterFort Lauderdale, Florida
  • Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.

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