Lung Cancer Clinical Trial

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

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: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

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Full Description

OBJECTIVES:

Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer.
Determine the 2-year survival of patients treated with this regimen.
Determine the progression-free local control rate in patients treated this regimen.
Determine the tolerability of this regimen in these patients.
Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.

Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *No prophylactic nodal radiotherapy is administered

Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study.

Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.

Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
Measurable disease
Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
No more than small effusions seen on chest CT scan only
No supraclavicular adenopathy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

At least 12 weeks

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
Direct bilirubin no greater than 1.5 times ULN
AST no greater than 3 times ULN

Renal:

Creatinine clearance at least 40 mL/min

Cardiovascular:

No New York Heart Association class III or IV heart disease

Pulmonary:

FEV_1 at least 1 L or 35% of predicted

Other:

No grade 2 or greater peripheral neuropathy
No weight loss of 10% or more within the past 3 months
No uncontrolled infection
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
No other severe underlying disease that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic:

No prior biologic therapy for NSCLC
No concurrent biologic therapy
No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

No prior chemotherapy for NSCLC
No other concurrent chemotherapy

Endocrine therapy:

No prior endocrine therapy for NSCLC

Radiotherapy:

No prior radiotherapy for NSCLC

Surgery:

No prior surgery for NSCLC

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT00032032

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 39 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan, 49221, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville Michigan, 48144, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe Michigan, 48162, United States
MeritCare Bemidji
Bemidji Minnesota, 56601, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Broadway
Fargo North Dakota, 58122, United States
Wood County Oncology Center
Bowling Green Ohio, 43402, United States
Fremont Memorial Hospital
Fremont Ohio, 43420, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee Ohio, 43537, United States
St. Luke's Hospital
Maumee Ohio, 43537, United States
St. Charles Mercy Hospital
Oregon Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky Ohio, 44870, United States
North Coast Cancer Care, Incorporated
Sandusky Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
Toledo Hospital
Toledo Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43617, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Fredericksburg Oncology, Incorporated
Fredericksburg Virginia, 22401, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse Wisconsin, 54601, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT00032032

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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