Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00274859
• Other study ID #: CDR0000454320
• Secondary ID: GERCOR-SEGEMOX-S
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: July 23, 2008
• Start date: August 2005

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
France	C.H.G. Beauvais	Beauvais
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	Centre Jean Perrin	Clermont-Ferrand
France	Intercommunal Hospital	Montfermeil
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Polyclinique De Courlancy	Reims
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier de Saint-Quentin	Saint-Quentin
France	C.H. Senlis	Senlis
France	Centre Paul Strauss	Strasbourg
France	Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer	Toulon - Cedex
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate			No
Secondary	Clinical benefit			No
Secondary	Tolerability			Yes
Secondary	Progression-free			No
Secondary	Overall survival			No