Phase 2
N=36
Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy
Adenocarcinoma of the Prostate · Recurrent Prostate Cancer · Stage IV Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00331344 ↗Enrolled (actual)
36
Serious AEs
21.6%
Results posted
Oct 2017
Primary outcome: Primary: Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II) — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mitoxantrone hydrochloride (Drug); ixabepilone (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II) |
25 | — |
| PRIMARY Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I) |
62 | — |
| PRIMARY Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I). |
0; 0; 0; 1; 2; 2 | — |
| SECONDARY Time to Progression (Phase II) |
4.4 | — |
Summary
This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, 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
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate
- Progressive metastatic disease (i.e., positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist therapy)
- Progressive disease after discontinuing hormonal therapy
- Progressive disease is based on any of the following*:
- Transaxial imaging
- Rise in prostate-specific antigen (PSA)
- Radionuclide bone scan (must show new metastatic lesions)
- Nonmeasurable or measurable disease
- For measurable disease, progression is defined by RECIST criteria
- Positive bone scan and elevated PSA required for nonmeasurable disease
- PSA evidence of progressive prostate cancer during or after first-line chemotherapy consists of a PSA level ≥ 2 ng/mL that has risen on ≥ 2 successive occasions ≥ 1 week apart
- Received ≥ 3 prior courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or after cessation of therapy
- No more than 1 prior chemotherapy regimen
- Re-treatment with the same taxane-based regimen allowed
- Changes in prior chemotherapy regimen (addition of other agents) for disease progression are considered 2 chemotherapy regimens, and are not allowed
- PSA ≥ 2 ng/mL
- Testosterone 40 mL/min
- ALT and AST grade 1
- No known prior severe hypersensitivity reactions to agents containing Cremophor® EL
- No "currently active" second malignancy other than nonmelanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to be at < 30% risk of relapse
- Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment
- See Disease Characteristics
- No prior mitoxantrone hydrochloride, ixabepilone, or other epothilones
- At least 4 weeks since prior hormonal therapy (i.e., any dose of megestrol, finasteride, or any herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES]) other than LHRH agonist or a stable dose of corticosteroids from a prior chemotherapy regimen
- More than 4 weeks since other prior systemic therapies for prostate cancer
- At least 4 weeks since prior radiation therapy
- More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- No concurrent moderate to strong CYP3A4 inhibitors
- No concurrent prophylactic colony-stimulating factors
- No concurrent radiotherapy
Data sourced from ClinicalTrials.gov (NCT00331344). 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.