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A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer


OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with
advanced non-small cell lung cancer treated with oxaliplatin plus paclitaxel. II. Assess the
overall survival, time to tumor progression, and toxicities associated with this combination
regimen in this patient population. III. Assess the neurologic toxicity of this combination
regimen and its correlation with creatinine clearance in these patients.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour followed by
oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed for at least 2 years or
until death.

PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study within 24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Stage IIIB with pleural effusion OR Stage IV OR Recurrent disease
Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100%
Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic:
Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL
OR Creatinine clearance at least 50 mL/min BUN less than 1.5 times normal Cardiovascular:
No symptomatic congestive heart failure No unstable angina or myocardial infarction within
the past 6 months No evidence of heart block greater than first degree, bundle branch
block, or ventricular or supraventricular arrhythmia Other: No allergy to platinum
compounds or antiemetics appropriate for study No other uncontrolled illness No active or
ongoing infection No evidence of peripheral neuropathy by physical exam or history Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for advanced NSCLC At least 4 weeks since prior chemotherapy Endocrine
therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery:
Not specified Other: No other concurrent investigational agents No concurrent
antiretroviral therapy for HIV positive patients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Ann M. Mauer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

10014

NCT ID:

NCT00004126

Start Date:

November 1999

Completion Date:

August 2003

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
University of Chicago Cancer Research Center Chicago, Illinois  60637
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Evanston Northwestern Health Care Evanston, Illinois  60201
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
University of Illinois at Chicago Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617