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Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer
Phase 1, PHASE2 trial testing Cabazitaxel in Castration Levels of Testosterone in 170 participants. Completed in 9 December 2019.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 11 July 2012 |
| Primary completion | 9 December 2019 |
| Estimated completion | 9 December 2019 |
| Sites | 2 locations across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The MTD was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity.
| Group | Value | 95% CI |
|---|---|---|
| Phase I Cabazitaxel + Carboplatin | 25 |
PFS is the time from the first dose until progression of disease or death, whichever comes first. PFS times will be estimated using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 4.5 | 3.5 – 5.7 |
| Phase II Cabazitaxel + Carboplatin | 7.3 | 5.5 – 8.2 |
Percentage of participants with a greater than 50% decrease in measurable values of PSA during treatment from their baseline PSA.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 40.9 | 30.2 – 51.8 |
| Phase II Cabazitaxel + Carboplatin | 61.7 | 51.4 – 72.6 |
Percentage of participants with a greater than 50% decrease in measurable values of bone-specific alkaline phosphatase during treatment from their baseline values
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 29.4 | 19 – 39 |
| Phase II Cabazitaxel + Carboplatin | 62 | 51.4 – 72.6 |
Percentage of participants with a greater than 50% decrease in measurable values of urine n-telopeptides during treatment from their baseline values.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 55 | 33.2 – 76.8 |
| Phase II Cabazitaxel + Carboplatin | 62.5 | 42.1 – 81.9 |
Time from date of treatment start until date of death due to any cause or last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 17.3 | 13.8 – 21.9 |
| Phase II Cabazitaxel + Carboplatin | 18.5 | 16.7 – 21.9 |
Grade 3: Serious reaction which requires medical treatment Grade 4: Life threatening. Grade 5 Death.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 9 | |
| Phase II Cabazitaxel + Carboplatin | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 4 | |
| Phase II Cabazitaxel + Carboplatin | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 4 | |
| Phase II Cabazitaxel + Carboplatin | 16 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Cabazitaxel | 1 | |
| Phase II Cabazitaxel + Carboplatin | 14 |
PFS and OS were reported for participants with and without AVPC-MS in the cabazitaxel vs cabazitaxel + carboplatin treatment groups
| Group | Value | 95% CI |
|---|---|---|
| AVPC-MS Postive | 1.7 | 1.3 – NA |
| AVPC-MS Negative | 6.3 | 5.9 – 10.9 |
| Group | Value | 95% CI |
|---|---|---|
| AVPC-MS Postive | 7.5 | 4.4 – 9.6 |
| AVPC-MS Negative | 6.5 | 3.9 – 8.4 |
| Group | Value | 95% CI |
|---|---|---|
| AVPC-MS Postive | 8.5 | 4.8 – NA |
| AVPC-MS Negative | 21.7 | 17.4 – NA |
| Group | Value | 95% CI |
|---|---|---|
| AVPC-MS Postive | 20.2 | 13.3 – 37.2 |
| AVPC-MS Negative | 21.5 | 9.1 – NA |
Time frame: 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I Cabazitaxel + Carb… | Phase I Cabazitaxel + Carb… | Phase I Cabazitaxel + Carb… | Phase II Cabazitaxel | Phase II Cabazitaxel + Car… |
|---|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — | — |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | — | — | — | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — | — | — | — |
| WBC decreased | Investigations | — | — | — | — | — |
| Reaction | System | Phase I Cabazitaxel + Carb… | Phase I Cabazitaxel + Carb… | Phase I Cabazitaxel + Carb… | Phase II Cabazitaxel | Phase II Cabazitaxel + Car… |
|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Hypomagnesenia | Metabolism and nutrition disorders | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| WBC decreased | Investigations | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — |
| Neuropathy | Nervous system disorders | — | — | — | — | — |
| Paresthesia | Nervous system disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — |
| Weight loss | Investigations | — | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — | — |
| Hematuria | Renal and urinary disorders | — | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — |
| Pain | Gastrointestinal disorders | — | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Malaise | General disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — | — |
| Epitaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Flu like symptoms | General disorders | — | — | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hyponatrenia | Metabolism and nutrition disorders | — | — | — | — | — |
Most-reported serious reactions: Acute Kidney Injury, Diarrhea, Fever, Hyponatremia, Upper gastrointestinal hemorrhage, Urinary tract infection, WBC decreased.
Data from ClinicalTrials.gov NCT01505868 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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