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| Sponsor: | Ireland Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003917 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.
PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: topotecan hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 1999 |
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Veterans Affairs Medical Center - Phoenix (Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Pacific Coast Hematology/Oncology Medical Group | |
| Fountain Valley, California, United States, 92708 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| Sidney Kimmel Cancer Center | |
| San Diego, California, United States, 92121 | |
| Southwest Cancer Care | |
| Poway, California, United States, 92064 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| United States, Colorado | |
| Oncology Clinic, P.C. | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Florida | |
| Baptist Hospital- Pensacola | |
| Pensacola, Florida, United States, 32522 | |
| Baptist Regional Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Shands Cancer Center | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Medical College of Georgia Hospital and Clinics | |
| Augusta, Georgia, United States, 30912-3620 | |
| United States, Illinois | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| United States, Indiana | |
| Oncology and Hematology Associates, Inc. | |
| Indianapolis, Indiana, United States, 46219 | |
| United States, Louisiana | |
| Alton Ochsner Medical Foundation Hospital | |
| New Orleans, Louisiana, United States, 70121 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| St. Joseph Mercy Hospital | |
| Pontiac, Michigan, United States, 48341-2985 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| St. John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Cooper Cancer Institute | |
| Camden, New Jersey, United States, 08103 | |
| Cooper Hospital/University Medical Center | |
| Voorhees, New Jersey, United States, 08043 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New Mexico | |
| Santa Fe Hematology/Oncology | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Salem Research | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| Central Pennsylvania Hematology & Medical Oncology Associates, PC | |
| Lemoyne, Pennsylvania, United States, 17043-1440 | |
| Penn State Geisinger Cancer Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Brown University Oncology Group | |
| Providence, Rhode Island, United States, 02912 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| Spartanburg Regional Healthcare System | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| Sarah Cannon-Minnie Pearl Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Texas Cancer Care | |
| Fort Worth, Texas, United States, 76104 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| Joe Arrington Cancer Center | |
| Lubbock, Texas, United States, 79410 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| United States, Virginia | |
| Hematology & Oncology Associates of Virginia | |
| Richmond, Virginia, United States, 23226 | |
| Office of Michael E. Lee | |
| Norfolk, Virginia, United States, 23502 | |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Wisconsin | |
| Waukesha Memorial Hospital | |
| Waukesha, Wisconsin, United States, 53188 | |
| Study Chair: | Nathan Levitan, MD | Case Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067097, CWRU-SKF-1598, SB-104864-A/396, NCI-G99-1524 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003917 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasms, Germ Cell and Embryonal Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial |