Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075543
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: docetaxel Drug: oxaliplatin Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.
  • Determine the toxicity of this regimen in these patients.


  • Determine the tolerance profile of patients treated with this regimen.
  • Determine a recommended phase III dose of this regimen in these patients.
  • Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.
  • Determine the complete pathological response in patients treated with this regimen as first-line therapy.
  • Determine the duration of the objective response in patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Study Start Date : July 2003

Primary Outcome Measures :
  1. Maximum tolerated dose of docetaxel and oxaliplatin
  2. Toxicity

Secondary Outcome Measures :
  1. Tolerance profile
  2. Recommended phase III dose
  3. Efficacy
  4. Complete pathological response
  5. Duration of the objective response
  6. Time to progression

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status

  • WHO 0-2 (0 in patients 70 to 75 years of age)

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.4 mg/dL


  • 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


Biologic therapy

  • Not specified


  • 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


  • More than 4 weeks since prior radiotherapy


  • Not specified


  • More than 28 days since prior participation in another clinical study
  • No other concurrent anticancer treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075543

Intercommunal Hospital
Montfermeil, France, 93370
Hopital Saint Antoine
Paris, France, 75012
Hopital Tenon
Paris, France, 75970
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Christophe Tournigand Hopital Saint Antoine Identifier: NCT00075543     History of Changes
Other Study ID Numbers: CDR0000346887
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2007

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action