Combination Chemotherapy, Radiation Therapy, and RSR13 in Treating Patients With Stage III Non-small Cell Lung Cancer

Sponsor

Spectrum Pharmaceuticals, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00004202

Collaborator

(none)

Locations

Actual Duration (Months)

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: chemotherapy Drug: efaproxiral Drug: paclitaxel Radiation: radiation therapy	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Induction Chemotherapy With Paclitaxel and Carboplatin Followed by Radiation Therapy With RSR13 for Locally Advanced Inoperable Non-Small Cell Lung Cancer

Actual Study Start Date :

Oct 1, 1998

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Cedars-Sinai Comprehensive Cancer Center	Los Angeles	California	United States	90048
3	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202
4	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21287
5	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
6	Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44195
7	Boston Cancer Group	Memphis	Tennessee	United States	38119
8	Dan Rudy Cancer Center	Nashville	Tennessee	United States	37205
9	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
10	Massey Cancer Center	Richmond	Virginia	United States	23298-0037
11	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
12	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
13	Centre Universitaire de Sante de l'Estrie - Site Fleurimont	Fleurimont	Quebec	Canada	J1H 5N4
14	Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4
15	Jewish General Hospital - Montreal	Montreal	Quebec	Canada	H3T 1E2
16	Notre Dame Hospital	Montreal	Quebec	Canada	H4L 2M1