NCT00274859

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
Last Updated

July 24, 2008

Status Verified

May 1, 2007

First QC Date

January 10, 2006

Last Update Submit

July 23, 2008

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

Secondary Outcomes (4)

  • Clinical benefit

  • Tolerability

  • Progression-free

  • Overall survival

Interventions

gemcitabine hydrochlorideDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

C.H.G. Beauvais

Beauvais, 60021, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre Hospitalier de Saint-Quentin

Saint-Quentin, 02321, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

Toulon, 83056, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Interventions

GemcitabineOxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Joseph Gligorov, MD

    Hopital Tenon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

August 1, 2005

Last Updated

July 24, 2008

Record last verified: 2007-05

Locations

FR(14)