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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00071929 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
| Study Start Date: | November 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment
Measurable disease by physical examination or medical imaging
Must have received 1 prior cytotoxic therapy regimen
1 additional noncytotoxic regimen allowed
Biologic or cytostatic agents include, but are not limited to:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 38 Study Locations| Study Chair: | Paula M. Fracasso, MD, PhD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
| Study ID Numbers: | CDR0000068235, GOG-0129K |
| Study First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00071929 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma |
|
Genital Diseases, Female Oxaliplatin Neoplasms Endometrial Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Pharmacologic Actions |