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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: etoposide; Drug: exisulind

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico School of Medicine Medical Sciences Campus
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Northeast Alabama Regional Medical Center
  • California
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Diego, California, United States, 92161
      • Veterans Affairs Medical Center - San Diego
    • San Francisco, California, United States, 94115
      • UCSF Comprehensive Cancer Center
    • San Francisco, California, United States, 94121
      • Veterans Affairs Medical Center - San Francisco
  • Delaware
    • Newark, Delaware, United States, 19713
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
    • Washington, District of Columbia, United States, 20422
      • Veterans Affairs Medical Center - Washington, DC
    • Washington, District of Columbia, United States, 20007
      • Lombardi Cancer Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital Comprehensive Cancer Center
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
    • West Palm Beach, Florida, United States, 33401
      • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612-7323
      • MBCCOP - University of Illinois at Chicago
    • Chicago, Illinois, United States, 60612
      • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60640
      • Louis A. Weiss Memorial Hospital
    • River Forest, Illinois, United States, 60305
      • West Suburban Center for Cancer Care
    • Rockford, Illinois, United States, 61108
      • Saint Anthony Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46885-5099
      • Fort Wayne Medical Oncology and Hematology, Incorporated
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Hematology Oncology Associates of the Quad Cities
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Baptist Hospital East - Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    • Baltimore, Maryland, United States, 21201
      • Veterans Affairs Medical Center - Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center - University Campus
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Medical Center - St. Joseph
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Veterans Affairs Medical Center - Minneapolis
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Cancer Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Veterans Affairs Medical Center - Columbia (Truman Memorial)
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • Siteman Cancer Center
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
    • Las Vegas, Nevada, United States, 89106
      • Veterans Affairs Medical Center - Las Vegas
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Buffalo, New York, United States, 14215
      • Veterans Affairs Medical Center - Buffalo
    • Elmhurst, New York, United States, 11373
      • Elmhurst Hospital Center
    • Jamaica, New York, United States, 11432
      • Queens Cancer Center of Queens Hospital
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center, NY
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell University
    • Syracuse, New York, United States, 13210
      • State University of New York - Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Veterans Affairs Medical Center - Syracuse
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Veterans Affairs Medical Center - Asheville
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Concord, North Carolina, United States, 28025
      • NorthEast Oncology Associates
    • Durham, North Carolina, United States, 27705
      • Veterans Affairs Medical Center - Durham
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Fayetteville, North Carolina, United States, 28302-2000
      • Cape Fear Valley Health System
    • Kinston, North Carolina, United States, 28503-1678
      • Lenoir Memorial Hospital Cancer Center
    • Pinehurst, North Carolina, United States, 28374
      • Firsthealth Moore Regional Hospital
    • Wilmington, North Carolina, United States, 28402-9025
      • New Hanover Regional Medical Center
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Veterans Affairs Medical Center - Fargo
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Lifespan: The Miriam Hospital
  • Texas
    • Dallas, Texas, United States, 75216
      • Veterans Affairs Medical Center - Dallas
    • Dallas, Texas, United States, 75235-9154
      • Simmons Cancer Center - Dallas
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Green Mountain Oncology Group
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
    • White River Junction, Vermont, United States, 05009
      • Veterans Affairs Medical Center - White River Junction
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates - Norfolk
    • Richmond, Virginia, United States, 23298-0037
      • MBCCOP - Massey Cancer Center
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • St. Mary's Medical Center
  • Wisconsin
    • Rhinelander, Wisconsin, United States, 54501
      • Ministry Medical Group - Northern Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: carboplatin + etoposide + exisulind; 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.

Drug: carboplatin; Drug: etoposide; Drug: exisulind

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
response rate	Up to 3 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Ramaswamy Govindan, MD, Washington University Siteman Cancer Center

Publications and helpful links

General Publications

• Govindan R, Wang X, Baggstrom MQ, Burdette-Radoux S, Hodgson L, Vokes EE, Green MR; Cancer and Leukemia Group B. A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer: CALGB 30104. J Thorac Oncol. 2009 Feb;4(2):220-6. doi: 10.1097/JTO.0b013e3181951eb0.
• Hanna M, Thipphawong J; 118 Study Group. A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008 Oct 31;7:17. doi: 10.1186/1472-684X-7-17.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: July 8, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: extensive stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anticarcinogenic Agents; Carboplatin; Etoposide; Sulindac sulfone
• Other Study ID Numbers: CALGB-30104; CLB-30104; CDR0000069439 (Registry Identifier: NCI Physician Data Query)