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Metastatic Castration-resistant Prostate CancerPhase 1NCT01594918

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

A Phase 1 study testing Cabazitaxel, Mitoxantrone and Prednisone in people with Metastatic Castration-resistant Prostate Cancer, run by Rahul Aggarwal at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cabazitaxel, Mitoxantrone and Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesUnited States
Study dates
Jun 2012to 23 Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Histologically confirmed adenocarcinoma of the prostate.
  • 2. Progressive metastatic prostate cancer (positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or LHRH agonist therapy).
  • 3. Patients may have either non-measurable disease OR measurable disease
  • 4. All patients must have a PSA ≥ 2 ng/mL.
  • 5. Progressive disease based on any one of the following:
  • transaxial imaging
Show all 31Show fewer
  • 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
  • 6. Testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
  • 7. ECOG Performance Status 0 -2.
  • 8. Required Laboratory values:
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  • Creatinine < 1.5 x upper limits of normal (ULN). If Cr. > 1.5 x ULN, then calculated creatinine clearance > 40cc/min.
  • ALT and AST within normal limits
  • Absolute neutrophil count > 2,000/mm3
  • Platelets > 100,000/ mm3
  • Hemoglobin > 8.0 gm/dL
  • Total bilirubin within normal limits
  • 9. Ejection fraction by MUGA scan or echocardiogram ≥ lower limit of institutional normal.
  • 10. Patients receiving hormonal therapy (i.e. any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES) other than LHRH agonist/antagonist or a stable dose of corticosteroid from a prior chemotherapy regimen must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease must be documented after discontinuation of the hormonal therapy.
  • 11. No other systemic therapies for prostate cancer within 28 days prior to initiation of this protocol.
  • 12. Prior radiation therapy completed ≥ 4 weeks prior to enrollment.
  • 13. No history of radiopharmaceuticals (strontium, samarium) for prostate cancer treatment.
  • 14. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. Should a patient's sexual partner become pregnant or suspect she is pregnant while the patient is participating in this study, he should inform the treating physician immediately.
  • 15. Life expectancy > 12 weeks.
  • 16. Age ≥ 18 years
  • 17. Inclusion of Minorities: Men and members of all ethnic groups are eligible for this trial.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients With Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy

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.

Read the detailed description

This is a Phase I, open label, dose-finding, multicenter clinical trial to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of cabazitaxel (25 mg/m2 IV q21 days) in combination with mitoxantrone (4-12 mg/m2 IV q21 days) and prednisone (5mg orally BID) in patients with metastatic CRPC who have not undergone prior chemotherapy for metastatic disease.

Up to five cohorts will be enrolled to determine the MTD and DLT profile of this combination. An accelerated titration design method is being used in order to minimize the number of patients exposed to subtherapeutic doses of mitoxantrone.

Being tested
Cabazitaxel, Mitoxantrone, Prednisone, Pegfilgrastim
Keywords
metastatic, CRPC, prostate, CAMP
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called Jevtana®, XRP6258, RPR116258

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

  • MitoxantroneDrug

    Also called Novantrone

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

  • PrednisoneDrug

    5 mg PO BID

  • PegfilgrastimDrug

    Also called Neulasta

    6 mg, SC, once every 21 days

Study groups in NCT01594918
Study groupRoleWhat they receive
Cabazitaxel, Mitoxantrone, PrednisoneExperimentalNot described
Receives: Drug: Cabazitaxel; Drug: Mitoxantrone; Drug: Prednisone; Drug: Pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Dose Limiting Toxicity (DLT)

    Number of Grade 3 or greater non-hematologic toxicity recorded.

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

  2. 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.

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

  3. Efficacy of drug combination including objective response rate and duration of response

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2016
  4. Study completion23 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01594918
Sponsor's protocol ID
UCSF Protocol No. 11951
Status last verified
Jul 2017
First submitted
7 May 2012
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cabazitaxel, Mitoxantrone and Prednisone in people with Metastatic Castration-resistant Prostate Cancer, run by Rahul Aggarwal at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Participants will be followed for the duration of treatment, an expected average of 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01594918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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