Clinical trial · Interventional
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diarrhea | — | UNRESOLVED | — |
| Hormone-resistant Prostate Cancer | — | UNRESOLVED | — |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cabazitaxel | Drug | Cabazitaxel | ALIAS |
| octreotide acetate | Drug | — | UNRESOLVED |
| octreotide pamoate | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (management of therapy complications)
- description
- Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: cabazitaxel
- Drug: prednisone
- Drug: octreotide pamoate
- Other: questionnaire administration
- Drug: octreotide acetate
Primary outcomes (1)
- measure
- Development of Grade 2 plus diarrhea
- timeFrame
- Baseline through 21 days after the last administration of cabazitaxel
- description
- Defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria as an increase in frequency of 4 or greater stools per day over baseline, incontinence, diarrhea warranting hospitalization or diarrhea limiting self-care activities of daily living (ADL). Baseline frequency will be defined in the pre-treatment assessment from cycle 1 as the maximum number of stools in one 24 hour period during the past 2 weeks. Any incidence of grade 2 or greater diarrhea during treatment or for up to 21 days after the last administration of cabazitaxel will be included in this endpoint.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed prostate cancer * Measurable disease on computed tomography (CT) or evaluable disease with an elevated PSA * Documented progression on (a) at least one prior hormone treatment, which must have incorporated luteinizing hormone-releasing hormone (LHRH) agonist therapy AND (b) at least one chemotherapy regimen, which must have included docetaxel; progression may be demonstrated by radiologic criteria or by PSA only if accompanied by new or worsening symptoms (pain progression) * Eastern Cooperative Oncology Group (ECOG) performance score of 0-2 * Absolute neutrophil count (ANC) more than or equal to 1500/ul * Hemoglobin more than or equal to 8.0 g/dL * Platelet count more than or equal to 100,000/ul * Serum creatinine less than or equal to 1.5x the upper limit of normal (ULN) * Bilirubin less than or equal to ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5x ULN * Must be recovered from acute and late effects of any prior surgery, radiotherapy or other anti-neoplastic therapy * Patients or their legal representatives must be able to read, understand, and provide informed consent * Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter * Palliative radiation for metastatic disease is allowed if less or equal to 40% of the total bone marrow was irradiated; 28 days must have elapsed since completion of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease * Concomitant bisphosphonate use is permitted if the dose had been stable for 12 weeks prior to enrollment Exclusion Criteria: * Treatment with radiotherapy, chemotherapy or any investigational agent in the prior 4 weeks * Major surgery in the prior 4 weeks * Prior treatment with cabazitaxel * Patients with known hypersensitivity to cabazitaxel, other drugs formulated with polysorbate 80 or octreotide * Inability to tolerate oral prednisone * Grade 2 or greater diarrhea in the prior 2 weeks * Grade 2 or greater neuropathy or stomatitis * Presence of an active uncontrolled infection or fever greater or equal to 38.5 degrees * Presence of parenchymal brain metastases; patients with neurological symptoms must have a CT or magnetic resonance imaging (MRI) of the brain showing no metastases within 60 days of enrollment * Prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months * History of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure (CHF) or recent myocardial infarction (MI)within 6 months of enrollment * Known human immunodeficiency virus (HIV) or hepatitis infection * Life expectancy less than 3 months * Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results * Lack of ability/willingness to give informed consent * Lack of ability/willingness to receive octreotide injection * Anticipated non-availability for study visits/procedures * Patients with uncontrolled diabetes, defined as a HbA1c greater than 7% or greater or equal to 8% despite therapy, or a fasting plasma glucose more than 2x ULN; at the investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
References
Publications (0)
Data not yet available