Full Text View
Tabular View
No Study Results Posted
Related Studies
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
This study is ongoing, but not recruiting participants.
First Received: January 9, 2004   Last Updated: July 23, 2008   History of Changes
Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075543
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: docetaxel
Drug: oxaliplatin
 Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Oxaliplatin Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of docetaxel and oxaliplatin [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance profile [ Designated as safety issue: Yes ]
  • Recommended phase III dose [ Designated as safety issue: No ]
  • Efficacy [ Designated as safety issue: No ]
  • Complete pathological response [ Designated as safety issue: No ]
  • Duration of the objective response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Study Start Date: July 2003
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075543

Locations
France
C.H. Senlis
Senlis, France, 60309
Hopital Saint Antoine
Paris, France, 75012
Hopital Tenon
Paris, France, 75970
Intercommunal Hospital
Montfermeil, France, 93370
Polyclinique De Courlancy
Reims, France, F-51100
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Christophe Tournigand Hopital Saint Antoine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000346887, FRE-GERCOR-DOCELOX/O-01-1, EU-20332
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075543     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
 Recurrence
Genital Diseases, Female
Docetaxel
Oxaliplatin
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
 Adnexal Diseases
Genital Diseases, Female
Docetaxel
Neoplasms
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services