Lung Cancer Clinical Trial

Combination Chemotherapy, Radiation Therapy, and RSR13 in Treating Patients With Stage III 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. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery.

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Full Description

OBJECTIVES: I. Determine the one year survival rate, two year survival rate, and median survival rate in patients with locally advanced unresectable non-small cell lung cancer treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13. II. Determine the complete and partial response rates and progression free interval in the chest (radiation portal) of these patients on this regimen. III. Determine the time to disease progression outside of the radiation portal in these patients on this regimen. IV. Determine the toxic effects and adverse events associated with this regimen in these patients.

OUTLINE: This is a multicenter study. Induction chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses. Radiotherapy: Beginning 3 to 4 weeks after induction chemotherapy, patients receive RSR13 IV over 30 minutes, followed by fractionated radiotherapy 5 times weekly for 6-7 weeks. Patients are followed monthly for 2 months and then every 3 months thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 46-48 patients will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced unresectable stage IIIA or IIIB non-small cell lung cancer (NSCLC), including: Squamous cell carcinoma OR Adenocarcinoma (including bronchoalveolar cell) OR Large cell anaplastic carcinoma (including giant and clear cell) OR Poorly differentiated NSCLC No small cell carcinoma No distant metastases Measurable or evaluable disease by chest x-ray, CT, or MRI scan Tumors adjacent to vertebral body are eligible if all gross disease is in the radiation boost field No pleural effusion(s) that are exudative, bloody, or cytologically malignant No asymptomatic brain metastases by CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion or epoetin alfa allowed) Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled serious cardiac disease No active congestive heart failure, unstable angina, pericardial effusion, or arrhythmia Pulmonary: FVC or FEV1 at least 50% Resting or exercise SaO2 on room air at least 90% by pulse oximetry Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active concurrent malignancy within the past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious medical or psychiatric illness that would preclude compliance No active serious infection No concurrent clinically significant peripheral neuropathy No prior significant allergic reaction to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No greater than 10% weight loss in the past 3 months

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent immunotherapy (during radiotherapy (RT) and RSR13 administration) Chemotherapy: No prior systemic chemotherapy No concurrent chemotherapy (during RT and RSR13 administration) Endocrine therapy: No concurrent hormonal therapy (during RT and RSR13 administration) Radiotherapy: No prior radiotherapy to the thorax Surgery: At least 1 week since prior diagnostic thoracoscopy OR At least 3 weeks since prior thoracotomy and recovered No prior total surgical resection Other: At least 3 weeks since other prior investigational agents or devices No prior RSR13

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00004202

Recruitment Status:

Completed

Sponsor:

Spectrum Pharmaceuticals, Inc

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There are 16 Locations for this study

See Locations Near You

Arizona Cancer Center
Tucson Arizona, 85724, United States
Cedars-Sinai Comprehensive Cancer Center
Los Angeles California, 90048, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21287, United States
Cancer Center of Albany Medical Center
Albany New York, 12208, United States
Cleveland Clinic Cancer Center
Cleveland Ohio, 44195, United States
Boston Cancer Group
Memphis Tennessee, 38119, United States
Dan Rudy Cancer Center
Nashville Tennessee, 37205, United States
Vanderbilt Cancer Center
Nashville Tennessee, 37232, United States
Massey Cancer Center
Richmond Virginia, 23298, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont Quebec, J1H 5, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
Jewish General Hospital - Montreal
Montreal Quebec, H3T 1, Canada
Notre Dame Hospital
Montreal Quebec, H4L 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00004202

Recruitment Status:

Completed

Sponsor:


Spectrum Pharmaceuticals, Inc

How clear is this clinincal trial information?

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