Know Cancer

forgot password

A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ramaswamy Govindan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center West Palm Beach, Florida  33401
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Weill Medical College of Cornell University New York, New York  10021
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Ministry Medical Group - Northern Region Rhinelander, Wisconsin  54501
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Siteman Cancer Center Saint Louis, Missouri  63110