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

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
cisplatin
efaproxiral
gemcitabine hydrochloride
paclitaxel
vinorelbine ditartrate
radiation therapy
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • North Idaho Cancer Center
  • Cancer Center at Lexington Clinic
  • Willis - Knighton Cancer Center
  • St. Agnes Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Providence Everett Medical Center - Pacific Campus
  • Schiffler Cancer Center
  • Algemeen Ziekenhuis Middelheim
  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute
  • Cancer Care Ontario-London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • CHUS-Hopital Fleurimont
  • Maisonneuve-Rosemont Hospital
  • Hopital Notre- Dame du CHUM
  • McGill University
  • Centre Hospitalier Universitaire de Quebec
  • Soroka University Medical Center
  • Rambam Medical Center
  • Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
May 8, 2013
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00055887
Brief Title
Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started. No patients were enrolled.
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
efaproxiral
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine ditartrate
Intervention Type
Procedure
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hak Choy, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Cancer Center at Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Willis - Knighton Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103-3951
Country
United States
Facility Name
St. Agnes Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Providence Everett Medical Center - Pacific Campus
City
Everett
State/Province
Washington
ZIP/Postal Code
98206
Country
United States
Facility Name
Schiffler Cancer Center
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
CHUS-Hopital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Notre- Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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