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DiarrheaPhase 2NCT01469338

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

A Phase 2 study testing cabazitaxel, prednisone and octreotide pamoate in people with Diarrhea and Hormone-resistant Prostate Cancer, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
cabazitaxel, prednisone and octreotide pamoate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Jul 2012to Nov 2014
Phase
Phase 2
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

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the impact of octreotide in reducing the incidence of grade 2 or greater diarrhea in men receiving cabazitaxel plus prednisone for castration-resistant prostate cancer (CRPC) after docetaxel therapy.

SECONDARY OBJECTIVES:

  1. Overall survival (OS).

II. Progression-free survival (PFS) (defined as the time between treatment start and the first date of progression as measured by objective tumor progression using the Response Evaluation Criteria In Solid Tumors (RECIST), pain progression or death).

III. Prostate-specific antigen (PSA) response rate.

IV. Objective response rate.

  1. Pain response.

VI. Toxicity.

OUTLINE:

Patients receive cabazitaxel as intravenous (IV) infusion over 1 hour on day 1, prednisone by mouth (PO) every day (QD), and octreotide pamoate given as intramuscular (IM) injection on day 1. Patients also receive octreotide acetate as a subcutaneous (SC) injection three times a day (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. After completion of study treatment, patients are followed up at 1 month, every 3 months until disease progression, and then every 6 months thereafter.

Being tested
cabazitaxel, prednisone, octreotide pamoate, questionnaire administration, octreotide acetate
Medical subject headings
Diarrhea, Prostatic Neoplasms

What participants receive

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

  • cabazitaxelDrug

    Also called Jevtana, RPR-116258A, taxoid XRP6258, XRP6258

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given PO

  • octreotide pamoateDrug

    Also called OP LAR, Sandostatin pamoate, Sandostatin pamoate LAR, SMS 201-995 pa

    Given IM

  • questionnaire administrationOther

    Ancillary studies

  • octreotide acetateDrug

    Also called Longastatin, Longastatina, Samilstin, SMS 201-995

    Given SC

Study groups in NCT01469338
Study groupRoleWhat they receive
Supportive care (management of therapy complications)ExperimentalPatients 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.
Receives: Drug: cabazitaxel; Drug: prednisone; Drug: octreotide pamoate; Other: questionnaire administration; Drug: octreotide acetate

What is being measured

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

  1. Development of Grade 2 plus diarrhea

    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.

    Measured: Baseline through 21 days after the last administration of cabazitaxel

Secondary outcomes (6)

  1. Progression-Free Survival

    Measured: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter

  2. Overall Survival

    Measured: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter

  3. RECIST response for patients with measurable disease

    Measured: Baseline, after every 4 courses, at the end of treatment, and then every 6 months

  4. Prostate-Specific Antigen response

    Measured: Baseline, day 1 of each course, at the end of treatment, and then every 6 months

  5. Pain palliation in patients with a baseline pain score greater or equal to 2

    Measured: Baseline, day 1 of each 3 week course, at the end of treatment, and then every 6 months for up to 52 weeks

  6. Toxicity (adverse events considered to be at least possibly drug-related)

    Measured: Baseline, day 1 of each course, and at the end of treatment

Timeline

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

  1. First posted10 Nov 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completionNov 2014

Why it stopped: lack of funding

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 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01469338
Sponsor's protocol ID
4P-11-3
Other IDs
NCI-2011-03266
Status last verified
Nov 2014
First submitted
1 Nov 2011
Last updated
24 Nov 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cabazitaxel, prednisone and octreotide pamoate in people with Diarrhea and Hormone-resistant Prostate Cancer, run by University of Southern California at 1 site 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 15 inclusion and 18 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: stopped early, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: lack of funding). Results are not available in the source record.

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?

Development of Grade 2 plus diarrhea (time frame: Baseline through 21 days after the last administration of cabazitaxel). 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 NCT01469338.

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 24 Nov 2014.

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