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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075543
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
  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 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Christophe Tournigand Hopital Saint Antoine
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 19, 2014