Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer

NCT01594918 | Completed Phase 1 DMC

• 1 other identifier: UCSF Protocol No. 11951
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects. The investigators want to find out what effects, good and/or bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

metastatic; CRPC; prostate; CAMP

Outcome Measures

Primary Outcomes (1)

• Determination of the maximum tolerated dose (MTD) of the combination of cabazitaxel and mitoxantrone/prednisone as chemotherapy for patients with metastatic CRPC who have not received prior chemotherapy for metastatic disease.

  Participants will be followed for the duration of treatment, an expected average of 4 months.

Secondary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  Participants will have AE/Toxicity evaluations every 21 days. Average study participation is approximately 4 months.

• Reduction in Prostate Specific Antigen (PSA), of the combination of cabazitaxel and mitoxantrone/prednisone in patients with metastatic CRPC who have not received prior chemotherapy for metastatic disease.

  Participants will have PSA assessments every 21 days. Average study participation is approximately 4 months.

• Efficacy of drug combination including objective response rate and duration of response

  Participants will be followed for the duration of treatment, an expected average of 4 months.

Study Arms (1)

Cabazitaxel, Mitoxantrone, Prednisone

EXPERIMENTAL

Drug: Cabazitaxel; Drug: Mitoxantrone; Drug: Prednisone; Drug: Pegfilgrastim

Interventions

Cabazitaxel DRUG

25 mg/m2 or 20 mg/m2, IV, once every 21 days

Also known as: Jevtana®, XRP6258, RPR116258

Cabazitaxel, Mitoxantrone, Prednisone

Mitoxantrone DRUG

4 mg/m2, 6 mg/m2, 8 mg/m2, 10 mg/m2, or 12 mg/m2, IV, once every 21 days

Also known as: Novantrone

Cabazitaxel, Mitoxantrone, Prednisone

Prednisone DRUG

5 mg PO BID

Cabazitaxel, Mitoxantrone, Prednisone

Pegfilgrastim DRUG

6 mg, SC, once every 21 days

Also known as: Neulasta

Cabazitaxel, Mitoxantrone, Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed adenocarcinoma of the prostate.
• \. Progressive metastatic prostate cancer (positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or LHRH agonist therapy).
• \. Patients may have either non-measurable disease OR measurable disease
• \. All patients must have a PSA ≥ 2 ng/mL.
• \. Progressive disease based on any one of the following:
• transaxial imaging
• a rise in PSA
• radionuclide bone scan
• Patients whose sole manifestation of progression is an increase in disease-related symptoms are not eligible.
• For patients with measurable disease, progression will be defined by the RECIST criteria.
• For patients with non-measurable disease, a positive bone scan and elevated PSA will be required. PSA evidence for progressive prostate cancer during or after first-line chemotherapy consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart. If the confirmatory PSA (#3) value is less (i.e., #3b) than the screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression for the purposes of eligibility.
• Radionuclide bone scan: new metastatic lesions
• \. Testosterone \< 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
• \. ECOG Performance Status 0 -2.
• \. Required Laboratory values:

You may not qualify if:

• Patients with significant cardiovascular disease including congestive heart failure (NYHA class III or IV), active angina pectoris or myocardial infarction within 6 months.
• Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with pre-existing neuropathy greater than CTCAE Grade 1 (motor or sensory).
• Patients with known prior severe hypersensitivity reactions to cabazitaxel or other agents containing polysorbate 80.
• Patients with known active brain metastases are excluded because of their poor prognosis. Head CT is NOT routinely required prior to enrollment. Patients with treated, asymptomatic brain metastasis will be eligible for enrollment.
• Patients with a "currently active" second malignancy other than non-melanoma skin cancer are excluded. \[Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.\]
• Concurrent use of moderate to strong CYP3A4 inhibitors is not allowed.

Sponsors & Collaborators

• Rahul Aggarwal: lead
• Sanofi: collaborator

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cabazitaxel; XRP6258; Mitoxantrone; Prednisone; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Rahul Aggarwal, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: June 23, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (3)