NCT00075543

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

5 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

July 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
Last Updated

July 24, 2008

Status Verified

July 1, 2007

First QC Date

January 9, 2004

Last Update Submit

July 23, 2008

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of docetaxel and oxaliplatin

  • Toxicity

Secondary Outcomes (6)

  • Tolerance profile

  • Recommended phase III dose

  • Efficacy

  • Complete pathological response

  • Duration of the objective response

  • +1 more secondary outcomes

Interventions

docetaxelDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial cancer * Stage III or IV disease * Metastatic peritoneal, lymphatic, or visceral disease * Measurable or evaluable disease * Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 (0 in patients 70 to 75 years of age) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN * Alkaline phosphatase less than 2.5 times ULN Renal * Creatinine no greater than 1.4 mg/dL Other * No serious uncontrolled infection * No intolerance to polysorbate 80 * No peripheral neuropathy greater than grade 1 * No neurological or mental disease that would preclude study participation * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen * No prior oxaliplatin or docetaxel Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 28 days since prior participation in another clinical study * No other concurrent anticancer treatment

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

Sponsors & Collaborators

Study Sites (5)

Intercommunal Hospital

Montfermeil, 93370, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

DocetaxelOxaliplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Christophe Tournigand

    Hopital Saint Antoine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

July 1, 2003

Last Updated

July 24, 2008

Record last verified: 2007-07

Locations

FR(5)