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

This study has been withdrawn prior to enrollment.
(Study never started. No patients were enrolled.)
Sponsor:
Information provided by:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00055887
First received: March 6, 2003
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: efaproxiral
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: vinorelbine ditartrate
Procedure: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Enrollment: 0
Study Start Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055887

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Kentucky
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
United States, Louisiana
Willis - Knighton Cancer Center
Shreveport, Louisiana, United States, 71103-3951
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
United States, Washington
Providence Everett Medical Center - Pacific Campus
Everett, Washington, United States, 98206
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Israel
Soroka University Medical Center
Beer-Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
Sheba Medical Center
Tel Hashomer, Israel, 52621
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Chair: Hak Choy, MD Simmons Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055887     History of Changes
Other Study ID Numbers: CDR0000271438, ALLOS-RSR13RT-013ELITE
Study First Received: March 6, 2003
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Spectrum Pharmaceuticals, Inc:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Vinorelbine
Cisplatin
Vinblastine
Carboplatin
Paclitaxel
Efaproxiral
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014