Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer - Full Text View

Sponsor:	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:	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:

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
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
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012