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Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

NCT ID: NCT00274859

Last Updated: 2008-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemcitabine hydrochloride

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role lead

Principal Investigators

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Joseph Gligorov, MD

Role: STUDY_CHAIR

Hopital Tenon

Locations

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C.H.G. Beauvais

Beauvais, , France

Site Status

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, , France

Site Status

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Intercommunal Hospital

Montfermeil, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Polyclinique De Courlancy

Reims, , France

Site Status

Centre Rene Huguenin

Saint-Cloud, , France

Site Status

Centre Hospitalier de Saint-Quentin

Saint-Quentin, , France

Site Status

C.H. Senlis

Senlis, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

Toulon, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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GERCOR-SEGEMOX-S04-1

Identifier Type: -

Identifier Source: secondary_id

LILLY-GERCOR-SEGEMOX-S04-1

Identifier Type: -

Identifier Source: secondary_id

SANOFI-GERCOR-SEGEMOX-S04-1

Identifier Type: -

Identifier Source: secondary_id

EU-20571

Identifier Type: -

Identifier Source: secondary_id

CDR0000454320

Identifier Type: -

Identifier Source: org_study_id