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

NCT00055887 | Withdrawn Phase 3

• 2 other identifiers: CDR0000271438ALLOS-RSR13RT-013ELITE
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 22

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IIIA non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer

Interventions

carboplatin DRUG

cisplatin DRUG

efaproxiral DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

vinorelbine ditartrate DRUG

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (22)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Cancer Center at Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

Willis - Knighton Cancer Center

Shreveport, Louisiana, 71103-3951, United States

Location

St. Agnes Cancer Center

Baltimore, Maryland, 21229, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Providence Everett Medical Center - Pacific Campus

Everett, Washington, 98206, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Carboplatin; Cisplatin; efaproxiral; Gemcitabine; Paclitaxel; Vinorelbine; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Hak Choy, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: November 1, 2002
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (8); BE (1); CA (9); IL (4)