Phase 2
Completed N=45
Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer
Fallopian tube cancer · Female Reproductive Cancer · Recurrent Breast Cancer · Ovarian Cancer
Source: ClinicalTrials.gov NCT00182767 ↗
Enrolled (actual)
45
Serious AEs
100.0%
Results posted
Mar 2016
Primary outcomePrimary: Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I) — 1; 1; 2; 0 participants
Summary
This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I) |
1; 1; 2; 0; 0 | — |
| PRIMARY Maximum Tolerated Dose |
16 | — |
| SECONDARY Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II) |
20; 7 | — |
| SECONDARY Progression-free Survival |
4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of 1 of the following: advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer (phase I and II) or metastatic breast cancer (phase I only).
- Platinum- and taxane-resistant disease, defined as a disease-free interval of = 2 prior regimens for metastatic breast cancer, including 1 taxane-based regimen in the adjuvant or metastatic setting (phase I).
- Meets 1 of the following criteria: Previously treated with a standard course of taxane- and platinum-based chemotherapy for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer, that is platinum-refractory or -sensitive disease (phase I );
- Measurable or evaluable disease, meeting 1 of the following criteria: unidimensionally measurable lesion, known disease and CA 125 > 50 U/mL on 2 occasions >= 1 week apart or known disease and CA 27-29, CA 15-3, or CA 125 > 50 U/mL on 2 occasions >= 1 week apart (for breast cancer patients)
- ECOG 0-2 or Karnofsky 60-100%
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered.
- At least 1 week since prior chemotherapy if given on a daily or weekly schedule and recovered.
- At least 3 weeks since prior radiotherapy and recovered.
- Recovered for more than 4 weeks from all adverse events related to prior agents.
- Normal organ function including:
- Normal bilirubin
- WBC >= 3,000/mm3
- Absolute neutrophil count >= 1,500/mm3
- Platelet count >= 100,000/mm3
- AST and ALT = = grade 2
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance.
- No other uncontrolled illness.
- No active brain metastases, including any of the following: evidence of cerebral edema by CT scan or MRI, evidence of disease progression on prior imaging studies, requirement for steroids or clinical symptoms of brain metastasis.
Data sourced from ClinicalTrials.gov (NCT00182767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.