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

• ClinicalTrials.gov Identifier: NCT00055887
• Recruitment Status: Withdrawn
• First Posted: March 7, 2003
• Last Update Posted: May 10, 2013
• Sponsor: Spectrum Pharmaceuticals, Inc
• Information provided by: Spectrum Pharmaceuticals, Inc

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 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 or disease	Intervention/treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: cisplatin; Drug: efaproxiral; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Drug: vinorelbine ditartrate; Procedure: radiation therapy	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Masking: None (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
• Study Start Date: November 2002

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

St. Agnes Cancer Center

Baltimore, Maryland, United States, 21229

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231-2410

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

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada, H1T 2M4

Hopital Notre- Dame du CHUM

Montreal, Quebec, Canada, H2L 4M1

McGill University

Montreal, Quebec, Canada, H2W 1S6

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

• ClinicalTrials.gov Identifier: NCT00055887 History of Changes
• Other Study ID Numbers: CDR0000271438; ALLOS-RSR13RT-013ELITE
• First Posted: March 7, 2003
• Last Update Posted: May 10, 2013
• Last Verified: May 2013

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:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Gemcitabine; Vinorelbine; Carboplatin; Efaproxiral; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antisickling Agents