A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the feasibility of the concurrent chemoradiotherapy regimen of
paclitaxel and vinorelbine with standard chest radiotherapy in patients with locally
advanced non-small cell lung cancer. II. Determine the maximum tolerated dose and dose
limiting toxicities of this regimen in this patient population. III. Determine the
radiologic response rate of induction chemotherapy with carboplatin and gemcitabine in this
patient population. IV. Evaluate the pathologic response rate in patients undergoing
resection. V. Evaluate the time to progression, overall survival, and quality of life in
this patient population.
OUTLINE: This is a dose escalation study of vinorelbine. Patients receive induction
chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine
IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. At 2
weeks following completion of induction chemotherapy, patients receive vinorelbine IV over
10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5
consecutive days a week on weeks 1-6. Following initial induction chemotherapy, patients
with stable or regressive disease may receive an additional 2-4 courses of carboplatin and
gemcitabine at investigator's discretion. At approximately 2-6 weeks following completion of
chemoradiotherapy, patients with resectable/operable disease undergo surgical resection.
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3
of 6 patients experience dose limiting toxicity. Quality of life is assessed in all
patients. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 38-47 patients will be accrued for this study within 12-18
months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIA or IIIB
non-small cell lung cancer Pathologic staging of mediastinal lymph nodes required (N2, N3)
Bidimensionally measurable disease by x-ray, CT scan, or MRI OR Evaluable disease (e.g.,
pulmonary infiltrate evaluable on x-ray) No malignant pleural effusions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal
(ULN) SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR
Creatinine clearance at least 50 mL/min Cardiovascular: No active cardiac ischemia No
congestive heart failure Other: No significant active infection No other severe
complicating medical illness (e.g., severe neurologic or psychiatric disease that would
prevent compliance) No concurrent malignancy except nonmelanoma skin cancer or carcinoma
in situ of the cervix Not pregnant or nursing Fertile patients must use effective
contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic or thoracic
radiotherapy Surgery: Not specified
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of the combination therapies
Outcome Description:
Toxicity will be assessed for each patient after each cycle of therapy. The maximum tolerated dose (MTD) will be the dose level prior to the dose in which greater than one-third of patients experience a dose-limiting toxicity.
Outcome Time Frame:
After each cycle of therapy
Safety Issue:
Yes
Principal Investigator
Gregory A. Masters, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 99L1
NCT ID:
NCT00004093
Start Date:
August 1999
Completion Date:
March 2002
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
