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

Lung Cancer Clinical Trial

Official title:

A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00055887
• Other study ID #: CDR0000271438
• Secondary ID: ALLOS-RSR13RT-01
• Status: Withdrawn
• Phase: Phase 3
• First received: March 6, 2003
• Last updated: May 8, 2013
• Start date: November 2002

Study information

• Verified date: May 2013
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• efaproxiral

• gemcitabine hydrochloride

• paclitaxel

• vinorelbine ditartrate

Procedure:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Hopital Notre- Dame du CHUM	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Rambam Medical Center	Haifa
Israel	Sheba Medical Center	Tel Hashomer
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Agnes Cancer Center	Baltimore	Maryland
United States	North Idaho Cancer Center	Coeur d'Alene	Idaho
United States	Providence Everett Medical Center - Pacific Campus	Everett	Washington
United States	Cancer Center at Lexington Clinic	Lexington	Kentucky
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Willis - Knighton Cancer Center	Shreveport	Louisiana
United States	Schiffler Cancer Center	Wheeling	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Israel,