Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT ID: NCT00055887

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

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 efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral.
• Compare time to progression, response rate, and pattern of failure of patients treated with these regimens.
• Determine the safety of efaproxiral in these patients.
• Determine the pharmacokinetics of efaproxiral in these patients.
• Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).

• Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:

• Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses.
• Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
• Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses.
• Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks.
• Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I.

Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

efaproxiral

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

vinorelbine ditartrate

Intervention Type: DRUG

radiation therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:

• Adenocarcinoma
• Squamous cell carcinoma
• Large cell carcinoma
• Poorly differentiated carcinoma
• Stage IIIA or IIIB

• T1 or T2, N2
• T3, N1 or N2
• T4, any N
• Any T, N3
• Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter
• Clinically or radiologically measurable disease of at least 2.0 cm
• Partially resected stage IIIB disease allowed provided a measurable lesion remains
• No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis
• No metastatic disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin at least 10 g/dL
• WBC at least 3,000/mm^3
• Absolute granulocyte count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No clinically active congestive heart failure
• No unstable angina
• No severe arrhythmia by ECG

Pulmonary

• FVC and FEV_1 at least 50% of normal
• Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air
• Exercise SpO_2 at least 90% on room air

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective contraception during and for 30 days after study therapy
• Male patients must use effective contraception during and for 90 days after study therapy
• No loss of more than 10% of body weight within the past 3 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No significantly altered mental status or dementia that would preclude giving informed consent
• No active infection
• No other serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 28 days since prior biologic therapy
• No concurrent colony-stimulating factors (randomized phase only)
• No biologic therapy during and for 1 month after study therapy
• No immune response modifiers during and for 1 month after study therapy

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• No hormonal therapy during and for 1 month after study therapy

Radiotherapy

• No prior thoracic radiotherapy

Surgery

• See Disease Characteristics
• No prior total surgical resection

Other

• More than 28 days since prior investigational drugs or devices
• No prior efaproxiral
• No other cytotoxic therapy during and for 1 month after study therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Principal Investigators

Hak Choy, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

North Idaho Cancer Center

Coeur d'Alene, Idaho, United States

Cancer Center at Lexington Clinic

Lexington, Kentucky, United States

Willis - Knighton Cancer Center

Shreveport, Louisiana, United States

St. Agnes Cancer Center

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Providence Everett Medical Center - Pacific Campus

Everett, Washington, United States

Schiffler Cancer Center

Wheeling, West Virginia, United States

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Hopital Notre- Dame du CHUM

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Soroka University Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

United States; Belgium; Canada; Israel

Other Identifiers

ALLOS-RSR13RT-013ELITE

Identifier Type: -

Identifier Source: secondary_id

CDR0000271438

Identifier Type: -

Identifier Source: org_study_id