Combination Chemotherapy and 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: NCT00033696
• 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 chemotherapy and radiation therapy may kill more tumor cells.

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

Detailed Description

OBJECTIVES:

* Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy.

* Determine the toxicity of this regimen in these patients.

* Determine the overall and failure-free survival of patients treated with this regimen.

* Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover.

* Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.

Patients with rapid disease progression discontinue study therapy.

Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-04-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-01
• Study Completion: 2009-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
chemotherapy + radiation therapy	topotecan hydrochloride	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
chemotherapy + radiation therapy	radiation therapy	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
chemotherapy + radiation therapy	carboplatin	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
chemotherapy + radiation therapy	paclitaxel	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
chemotherapy + radiation therapy	etoposide	Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Primary Outcome Measures

Name	Time	Method
overall response rate	up to 5 years

Secondary Outcome Measures

Name	Time	Method
overall survival	up to 5 years
failure-free survival	up to 5 years

Trial Locations

Locations (51)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

CCOP - Northern Indiana CR Consortium; 🇺🇸 South Bend, Indiana, United States

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

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

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

Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

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

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

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

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

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

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

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Holden Comprehensive Cancer Center; 🇺🇸 Iowa City, Iowa, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

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

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Green Mountain Oncology Group; 🇺🇸 Bennington, Vermont, United States

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

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

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

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

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

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

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