Clinical trial NCT00274859: Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Clinical benefit
measure: Tolerability
measure: Progression-free
measure: Overall survival
Other outcomes:
Locations:
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Boulogne Sur Mer
country: France
facility: Centre Hospitalier Docteur Duchenne
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Montfermeil
country: France
facility: Intercommunal Hospital
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin
city: Senlis
country: France
facility: C.H. Senlis
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulon - Cedex
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Hopital Tenon
name: Joseph Gligorov, MD
role: STUDY_CHAIR
References: