Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Biological: filgrastim; Drug: carboplatin; Drug: etoposide; Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: radiation therapy

• Registration Number: NCT00003812
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and giving them before and with radiation therapy may be an effective treatment for limited-stage small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan followed by consolidation chemoradiotherapy in patients with limited stage small cell lung cancer. II. Determine the toxic effects of this regimen in this patient population. III. Describe the pattern of relapse, documenting carefully the location of relapse with respect to the original disease volume and the radiation treatment field in these patients. IV. Determine the overall and failure free survival of these patients.

OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2004-06
• Study First Submitted QC: 2004-07-21
• Study First Posted: 2004-07-22
• Study Completion: 2006-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemotherapy + radiation therapy	filgrastim	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
chemotherapy + radiation therapy	topotecan hydrochloride	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
chemotherapy + radiation therapy	radiation therapy	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
chemotherapy + radiation therapy	carboplatin	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
chemotherapy + radiation therapy	etoposide	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
chemotherapy + radiation therapy	paclitaxel	Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.

Primary Outcome Measures

Name	Time	Method
overall survival	Up to 5 years
response rate	Up to 5 years

Trial Locations

Locations (48)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Illinois at Chicago Health Sciences Center; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital); 🇺🇸 Chicago, Illinois, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial); 🇺🇸 Columbia, Missouri, United States

CCOP - North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Memphis; 🇺🇸 Memphis, Tennessee, United States

Veterans Affairs Medical Center - Syracuse; 🇺🇸 Syracuse, New York, United States

Veterans Affairs Medical Center - Richmond; 🇺🇸 Richmond, Virginia, United States

State University of New York - Upstate Medical University; 🇺🇸 Syracuse, New York, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Winston-Salem, North Carolina, United States

Vermont Cancer Center; 🇺🇸 Burlington, Vermont, United States

University of Tennessee, Memphis Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Veterans Affairs Medical Center - White River Junction; 🇺🇸 White River Junction, Vermont, United States

CCOP - Southern Nevada Cancer Research Foundation; 🇺🇸 Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Veterans Affairs Medical Center - Durham; 🇺🇸 Durham, North Carolina, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

CCOP - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Ellis Fischel Cancer Center - Columbia; 🇺🇸 Columbia, Missouri, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Veterans Affairs Medical Center - Togus; 🇺🇸 Togus, Maine, United States

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.; 🇺🇸 Syracuse, New York, United States

Mount Sinai Medical Center, NY; 🇺🇸 New York, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

MBCCOP - Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Wilmington, Delaware, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Missouri Baptist Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Veterans Affairs Medical Center - Buffalo; 🇺🇸 Buffalo, New York, United States