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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Hak Choy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Simmons Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000271438
NCT ID:
NCT00055887
Start Date:
November 2002
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Schiffler Cancer Center | Wheeling, West Virginia 26003 |
| North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
| Cancer Center at Lexington Clinic | Lexington, Kentucky 40504 |
| St. Agnes Cancer Center | Baltimore, Maryland 21229 |
| Willis - Knighton Cancer Center | Shreveport, Louisiana 71103-3951 |
| Providence Everett Medical Center - Pacific Campus | Everett, Washington 98206 |
