Phase 2
N=170
Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer
Castration Levels of Testosterone · Castration-Resistant Prostate Carcinoma · Lymphadenopathy · Metastatic Prostate Carcinoma · Prostate Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01505868 ↗Enrolled (actual)
170
Serious AEs
4.1%
Results posted
Jul 2021
Primary outcome: Primary: Maximum Tolerated Dosage (MTD) of Cabazitaxel-carboplatin in the Phase I Portion of Study — 25 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabazitaxel (Drug); Carboplatin (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dosage (MTD) of Cabazitaxel-carboplatin in the Phase I Portion of Study |
25 | — |
| PRIMARY Progression Free Survival (PFS) of Cabazitaxel-carboplatin Versus Cabazitaxel in the Phase II Portion of Study |
4.5; 7.3 | — |
| SECONDARY Prostate Specific Antigen (PSA) Response Rate |
40.9; 61.7 | — |
| SECONDARY Bone-Specific Alkaline Phosphatase Response |
29.4; 62 | — |
| SECONDARY Urine N-Telopeptides Response |
55; 62.5 | — |
| SECONDARY Overall Survival (OS) |
17.3; 18.5 | — |
| SECONDARY Phase II Most Common Grade 3-5 Adverse Events |
9; 20; 4; 23; 4; 16 | — |
Summary
This partially randomized phase I/II trial studies cabazitaxel with or without carboplatin in treating patients with previously treated prostate cancer that has spread to other areas of the body and does not respond to treatment with hormones. Drugs used in chemotherapy, such as cabazitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cabazitaxel alone or with carboplatin is more effective in treating prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Histologic evidence of prostate adenocarcinoma
- In addition to patients with adenocarcinoma, patients with "anaplastic" features are also eligible as defined by at least one of the following: a) histologic evidence of small cell prostate cancer (patients with small cell carcinoma on histology are not required to demonstrate castration-resistant progression); b) any of the following metastatic presentations: (i) exclusive visceral metastases; (ii) radiographically predominant lytic bone metastases identified by plain X-ray or computed tomography (CT) scan; (iii) bulky (>= 5 cm in longest dimension) lymphadenopathy (iv) bulky (>= 5 cm) tumor mass in the prostate/pelvis (v) low PSA (= = 20) bone metastases; (vi) elevated serum lactate dehydrogenase (LDH) (>= 2 x ULN) or elevated serum carcinoembryonic antigen (CEA) (>= 2 x upper limit of normal [ULN]) in the absence of other etiologies; (vii) short interval (= = 1.5 cm in diameter
- Patients may have received prior treatment with androgen ablative therapies (such as bicalutamide, ketoconazole, diethylstilbestrol [DES], abiraterone, Xtandi, ARN-509) and/or "targeted" therapies (such as tyrosine kinase inhibitors); androgen ablative therapies must be discontinued >= 3 days prior to initiation of study treatment with the exception of abiraterone and/or enzalutamide, which may be continued during study treatment per the practice preference of the treating physician; patients who are predicted to benefit from an antiandrogen withdrawal response should be tested for this possibility before being considered for eligibility to this study; targeted therapies must be discontinued >= 2 weeks before initiation of study treatment
- Both chemotherapy-naive and patients previously treated with chemotherapy are eligible; chemotherapy pretreated patients may have received a maximum of two prior systemic cytotoxic chemotherapies completed at least 3 weeks prior to initiation of study treatment
- Patients must have documented evidence of progressive disease as defined by any of the following: a) PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least >= 2.0 ng/mL; b) new or increasing non-bone disease (by Response Evaluation Criteria In Solid Tumors [RECIST]); c) positive bone scan with 2 or more new lesions (Prostate Cancer Working Group [PCWG2])
- For purposes of stratification, patients will be categorized as "responders" or "non-responders" based on their response to prior docetaxel-based therapy; a) responders will have demonstrated objective responses to first-line docetaxel as determined by any of the following: 1. decrease in PSA level >= 50% from baseline, maintained for >= 6 weeks; 2. partial or complete response in lymph nodes and soft tissue metastases by RECIST; responders must have received >= 225 mg/m^2 (~ 3 cycles) of docetaxel; b) patients not meeting response criteria above will be considered as non-responders; we anticipate 2 general categories of non-responders based on the following disease phenotypes: 1. progressive disease on therapy without any objective evidence of response ("primary-resistant disease"); progressive disease on therapy with prior objective evidence of response, but response duration is = = 1,500/ml (unless due to bone marrow infiltration by tumor in which case ANC >= 500/ml are allowed) (within 14 days before registration)
- Platelets >= 100, 000/ml (unless due to bone marrow infiltration by tumor in which case >= 50,000/ml are allowed) (within 14 days before registration)
- Total bilirubin = = 30 ml/min using the Cockcroft-Gault equation (within 14 days before registration)
- Men whose partner is a woman of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
- Patient or his legally authorized representative must provide written informed consent
- Eastern Cooperative Oncolog
Data sourced from ClinicalTrials.gov (NCT01505868). 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.