Clinical trial · Interventional
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
NCT00095979CI-TRIAL-00039709completedPhase 2Results postedClinicalTrials.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)
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.
Conditions
Conditions (3)
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 Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Recurrent Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ixabepilone)
- description
- Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ixabepilone
Primary outcomes (2)
- measure
- Tumor Response
- timeFrame
- Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
- description
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed endometrial adenocarcinoma
* Recurrent or persistent disease
* Histologic confirmation of the original primary tumor is required
* Not amenable to management with any of the following:
* Surgery
* Radiotherapy
* Higher priority or standard chemotherapy
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
* At least 1 target lesion
* Tumors within a previously irradiated field are designated as non-target lesions
* Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy
* Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma
* Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)
* Performance status - GOG 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST (aspartate aminotransferase) ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Sensory or motor neuropathy ≤ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other invasive malignancies within the past 5 years except non-melanoma skin cancer
* At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor
* One prior non-cytotoxic\* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed
* See Disease Characteristics
* Prior paclitaxel or docetaxel allowed
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
* No prior ixabepilone
* At least 1 week since prior hormonal therapy directed at the malignant tumor
* Continuation of hormone replacement therapy allowed
* See Disease Characteristics
* Recovered from prior radiotherapy
* Recovered from prior surgery
* At least 3 weeks since other prior therapy directed at the malignant tumor
* No prior cancer treatment that contraindicates study therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.