Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic cancer not amenable
to anthracycline or taxane therapy treated with gemcitabine hydrochloride and
oxaliplatin.
Secondary
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer
- Metastatic disease
- Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
- Not a candidate for anthracycline or taxane chemotherapy
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Creatinine < 1.5 times ULN OR creatinine clearance > 30 mL/min
- SGOT and SGPT < 3 times ULN (5 times ULN if liver metastases present)
- No pre-existing neuropathy
- Not pregnant or nursing
- No uncontrolled hypercalcemia
- No familial, social, geographical, or psychological condition that would preclude
study treatment
- No other malignancy that is not considered cured
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
- Prior hormonal therapy allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Safety Issue:
No
Principal Investigator
Joseph Gligorov, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Tenon
Authority:
United States: Federal Government
Study ID:
CDR0000454320
NCT ID:
NCT00274859
Start Date:
August 2005
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|
