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Prostate CancerPhase 1NCT01378091

Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer

A Phase 1 study testing Lenalidomide, Docetaxel and Prednisone in people with Prostate Cancer, run by Columbia University at 2 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

Primary objectives: To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer To evaluate the safety profile of the combination of daily lenalidomide and every three week… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lenalidomide, Docetaxel and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesUnited States
Study dates
Aug 2005to Sep 2013
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

  • Subjects must understand and voluntarily sign an informed consent document.
  • Age > 18 years at the time of signing informed consent form.
  • Histological documentation of prostate cancer.
  • Subjects must be able to adhere to the study visit schedule and other protocol requirements.
  • Radiographic or clinical evidence of measurable or evaluable androgen independent prostate cancer stages D1 or D2.
  • Patients must be surgically or medically castrated. If the method is medical castration, the patient must have a serum testosterone level of <50 ng/dl/. The patient should maintain treatment with LH RH antagonists or agonists.
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  • Patients must have metastatic prostate cancer unresponsive or refractory to androgen blockade by one or more of the following criteria:
  • Progression of unidimensionally measurable disease.
  • Progression of non measurable disease
  • Rising PSA (absolute value of PSA > 5 mg/ml).
  • Rising PSA is defined as at least 2 consecutive rises in PSA to be documented over the reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA is required, and it must be obtained at least seven days after the second measure. If the third measure does not confirm the rise in PSA, a fourth PSA measure is required to be taken to confirm the rise over the second measure.
  • Patients who were treated with antiandrogens such as flutamide, or other hormonal agents such as estrogens, or ketoconazole must have been stopped for at least 28 days prior to enrollment. In the case of nilandron and bicalutamide, treatment with these agents must have stopped at least 42 days prior to treatment. If the patient is being treated with corticosteroids, the dose should be stable for 14 days prior to study entry
  • ECOG performance status of ≤2 (Appendix I: ECOG Performance Status Scale).
  • Regarding Lenalidomide: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix V: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix VI: Education and Counseling Guidance Document.
  • Laboratory values as indicated below:
  • Serum Creatinine <2.0 mg/dL
  • Absolute Neutrophil Count ≥1,500/mm3 (or 1.5 X109/L)
  • Platelet Count >100,000/mm3 (or 100 x 109/L)
  • Aspartate Aminotransferase (AST/SGOT) ≤ 1.5 x upper limit of normal (ULN)
  • Alkaline Phosphatase < 2.5 x ULN (In the absence of liver metastasis, elevated alk phos due to bone mets is permitted)
  • Conjugated Bilirubin < ULN

Who cannot join

  • Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
  • More than 2 prior regimens of chemotherapy.
  • Use of thalidomide or biologic response modifier therapy within 28 days of initiation of therapy
  • Prior desquamating rash while taking thalidomide therapy.
  • Prior > grade-2 allergic reaction to thalidomide.
  • Any prior use of lenalidomide. Subjects may have received prior thalidomide therapy.
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  • Concurrent use of any other anti-cancer agents, excluding bisphosphonates.
  • Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
  • Active infection, known positive for HIV or hepatitis B or C.
  • Known hypersensitivity or intolerance to taxanes or polysorbate 80.
  • Known hypersensitivity reaction to thalidomide
  • Use of any other experimental drug or therapy within 28 days.
  • Subjects with > grade-2 neuropathy.
  • Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast, or superficial bladder cancer) unless the subject has been free of disease for > 3 years.
  • Prior whole pelvic radiation, or prior treatment with strontium. Prior treatment with samarium is permitted.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Columbia University Medical Center

    New York, New York, 10032

  • Cornell Weill Medical Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Every Three Week Docetaxel (Taxotere®) In Subjects With Androgen Independent Prostate Cancer

Primary objectives:

To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer

To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer

Secondary objective:

To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.

Read the detailed description

Adenocarcinoma of the prostate is the second leading cause of cancer death in men. There is medication available to help treat this disease, which typically lengthens life by 10 to 12 months. More recent studies have shown average survivals of 20 to 23 months.

The investigators hope that the experimental (research) drug called lenalidomide (Revlimid®), which is being used in this study, will lengthen the lives of these patients by even more time. A different drug in the same drug family has demonstrated activity against a variety of solid tumors as well as hematological malignances. It works against cancer in different ways than chemotherapy by affecting the immune system (the body's ability to naturally fight disease).

The investigators believe that the study drug helps build up patients' immune systems than some of the other popular drugs on the market, and may potentially increase survival rates for patients with hormone refractory prostate cancer.

Conditions
Prostate Cancer
Keywords
Androgen Independent Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    Supplied as 5 mg and 25 mg capsules.

    The lenalidomide dose levels to be studied include 10, 15, 20, 25, 30, 35 and 40 mg/day.

  • DocetaxelDrug

    Also called Taxotere®

    Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug.

    Doses of docetaxel to be studied include 60 and 75 mg/m2 once every three weeks.

  • PrednisoneDrug

    Also called Deltasone

    Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug.

    5 mg BID daily.

Study groups in NCT01378091
Study groupRoleWhat they receive
Lenalidomide, Docetaxel, PrednisoneExperimentalSubjects will receive this drug combination during a treatment phase and an extension phase.
Receives: Drug: Lenalidomide; Drug: Docetaxel; Drug: Prednisone

What is being measured

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

  1. Maximum tolerated dose (MTD) of lenalidomide

    The MTDs of lenalidomide, docetaxel and prednisone when given as combination therapy will be defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity (DLT).

    Measured: Up to 2 years

Timeline

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

  1. First posted22 Jun 2011 (estimated)
  2. Study startAug 2005
  3. Primary completionSep 2013
  4. Study completionSep 2013

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01378091
Sponsor's protocol ID
AAAB3212
Status last verified
May 2016
First submitted
20 Jun 2011
Last updated
9 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide, Docetaxel and Prednisone in people with Prostate Cancer, run by Columbia University at 2 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 21 inclusion and 15 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 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Maximum tolerated dose (MTD) of lenalidomide (time frame: Up to 2 years). 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 NCT01378091.

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 9 May 2016.

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