Clinical trial · Interventional
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
NCT00030706CI-TRIAL-00035073completedPhase 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 ixabepilone, 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 ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of clinical remission
- timeFrame
- up to 12-months post-treatment
- description
- number of participants experience clinical remission will be determined
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma
* Recurrent or refractory disease
* Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
* Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* Bidimensionally measurable disease by physical exam, CT scan, or MRI
* Ascites and pleural effusions are not measurable disease
* No prior irradiation to indicator lesions
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No prior bleeding disorder or unexplained bleeding
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT/SGPT 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
Other
* No active infection requiring antibiotics
* No grade 2 or greater neuropathy (sensory and motor)
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
* No other medical condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No prior ixabepilone
* No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
Endocrine therapy
* At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
* Concurrent hormonal replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to a site of measurable disease used on study
* No prior radiotherapy to more than 25% of bone marrow
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
* No prior cancer treatment for other invasive malignancies that would preclude study participation
* No concurrent heparin or other anticoagulants
* No concurrent Hypericum perforatum (St. John's wort) or any product containing this compoundReferences
Publications (0)
Data not yet available
No reference posted for this study.