Clinical trial · Interventional
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
NCT00071929CI-TRIAL-00010977completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 participationReferences
Publications (1)
- RESULTFracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19. PMID 16712905