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Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00071929
Enrollment
Unknown
Registered
2003-11-06
Start date
1999-11-30
Completion date
2007-09-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma

Brief summary

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.

Detailed description

OBJECTIVES: * Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy. * Determine the nature and degree of toxicity of this treatment regimen in these patients. 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.

Interventions

DRUGoxaliplatin

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment * Clinically and/or histologically confirmed persistent or recurrent disease * Measurable disease by physical examination or medical imaging * Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable * Ascites or pleural effusions not considered measurable * Must have received 1 prior cytotoxic therapy regimen * May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment * 1 additional noncytotoxic regimen allowed * Biologic or cytostatic agents include, but are not limited to: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * Ineligible for a higher priority GOG protocol * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 if received 1 prior therapy regimen * GOG 0-1 if received 2 prior therapy regimens 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 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Neurologic * No sensory or motor neuropathy greater than grade 1 * No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergy to platinum compounds or antiemetics * No active infection requiring antibiotics * No other uncontrolled illness * No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 14 days since prior pegfilgrastim * At least 24 hours since other prior growth factors * At least 3 weeks since prior biologic or immunologic therapy * No concurrent growth factors during first course of study therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy * No prior oxaliplatin Endocrine therapy * At least 1 week since prior hormonal therapy directed at tumor * Concurrent hormone replacement therapy allowed Radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery * Recovered from any recent surgery Other * At least 3 weeks since prior therapy for endometrial cancer * No other concurrent investigational agents * No prior anticancer therapy that would preclude study participation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026