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Prostate CancerPhase 1NCT00933426

Lenalidomide and Paclitaxel in Prostate Cancer

A Phase 1 study testing Lenalidomide and Paclitaxel in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes. 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 and Paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Aug 2009to Dec 2015
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

  • Patients with metastatic adenocarcinoma of the prostate
  • Patients in Phase II must have radiographic evidence of multiple (>/= 2) or bulky (>/= 5cm diameter) lymph node metastases with < 2 bone (on radionuclide bone scan) discrete sites of involvement.
  • Patient must have had front-line chemotherapy for castrate-resistant metastatic disease. Any number of prior chemotherapy regimens is permitted, except within the last 3 weeks. No prior thalidomide or lenalidomide therapy is permitted.
  • Patients must have evidence of progression of disease based on any one of the following criteria: a) PSA- progression is defined as 2 consecutive increments in PSA (with an absolute change of at least 1ng/mL) over 4 weeks. b) An increase by 25% of the product of bi-dimensional disease or 30% in maximum diameter or appearance of an unequivocally new lesion qualifies as progression. c) Worsening symptoms clearly attributable to disease progression qualifies as progression e.g. worsening malignant bony pain.
  • Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
  • Patients must have a performance status of </= 2 (ECOG).
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  • Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
  • Patients must have recovered from prior chemotherapy, biological or immunological therapy or radiation delivered within the last 28 days. Radioisotope therapy with strontium delivered within the last 90 days or samarium within the last 60 days is not permitted.
  • Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
  • Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 75,000/mm^3.
  • Patients must have adequate hepatic function defined with a bilirubin of </= 2 X upper limits of normal and AST/ALT </= 2.5 X the upper limits of normal.
  • Patients must have adequate renal function defined as creatinine clearance >/= 40 cc/min (measured or calculated by Cockcroft and Gault formula).
  • Must be fully recovered from any previous surgery, in terms of wound healing.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  • Men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy. A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patient must be able to take low molecular weight heparin (preferred) OR low-dose enteric aspirin and warfarin for thromboembolic prophylaxis.

Who cannot join

  • Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
  • Patients with small cell or sarcomatoid variant of prostate cancer.
  • Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 3 months or evidence of active myocardial ischemia by symptoms or electrocardiogram (ECG).
  • Known severe hypersensitivity to taxanes.
  • Patients with central nervous system (CNS) metastasis or cord compression are excluded except those patients that have had complete excision or radiotherapy and remain asymptomatic for at least 2 months.
  • Oxygen-dependent lung disease or >/= grade 2 peripheral neuropathy.
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  • Known intolerance of corticosteroid therapy that would preclude its use as premedication for paclitaxel.
  • Uncontrolled severe hypertension or uncontrolled diabetes mellitus.
  • Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder or Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
  • Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients who are unwilling or unable to comply with the RevAssist® program or with a history of non-compliance with medical regimens or who are considered potentially unreliable.
  • Patients with known HIV or active hepatitis A, B, or C infection.
  • Patients receiving any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
  • Patients who have not recovered from prior chemotherapy, biological or immunological therapy or radiation delivered within the last 28 days. Radioisotope therapy with strontium delivered within the last 90 days or samarium within the last 60 days is not permitted.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Modular Phase I-II Trial of Lenalidomide and Paclitaxel in Men With Castration-Resistant Prostate Cancer and Lymph-Node Dominant Metastases

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes.

The goal of the Phase II part of this clinical research study is to learn if lenalidomide and paclitaxel can help to control prostate cancer.

The safety of this combination treatment will be studied in both phases of the study.

UPDATE:

Study was terminated early due to slow accrual as a Phase I dose escalation study, without progression to Phase II study portion.

Read the detailed description

Study Drugs:

Lenalidomide is a drug that changes the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Taking lenalidomide could prevent the growth of cancer cells.

Paclitaxel is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.

Phases I and II:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined the study. Up to 10 groups of 3 participants will be enrolled in the Phase I portion of the study, and 1 group of up to 42 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the doses of lenalidomide you receive will depend on when you joined this study. The dose of paclitaxel will be the same for all patients. Up to 5 dose levels of lenalidomide will be tested in the Phase I portion. The first group of Phase I participants will receive the lower doses of lenalidomide. Each new group enrolled will receive the higher doses, if no intolerable side effects were seen. Groups will continue being enrolled (up to 10) until the highest tolerable dose of lenalidomide (in combination with paclitaxel) is found.

If you are enrolled in the Phase II portion, you will receive lenalidomide at the highest dose that was tolerated in the Phase I portion in combination with paclitaxel.

Study Drug Administration:

Once you are assigned a dose, you will take lenalidomide capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28). This will be called the "lead-in" period."

You will the begin taking lenalidomide and paclitaxel on 28 day study cycles. You will take lenalidomide by mouth every day on Days 1-21 of each cycle. Paclitaxel will be given by vein over 1 hour on Days 1, 8, and 15 of each cycle. On Days 22-28 of each cycle, you will take no study drugs. The Day 1 dose of Lenalidomide in each combination cycle may occur within +/- 5 days of the Day 1 paclitaxel dose.

You should swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew, or open the capsules.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day.

If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).

If you take more than the prescribed dose of lenalidomide you should seek emergency medical care, if needed, and contact study staff right away.

Females of childbearing potential that might be caring for you should not touch the lenalidomide capsules or bottles unless they are wearing gloves.

In order to participate in this study you must also register into and follow the requirements of the RevAssist® program of Celgene Corporation. This program provides education and counseling on the risks of fetal exposure, blood clots, and reduced blood counts. You will be required to receive counseling every 28 days during treatment with lenalidomide, follow the birth control requirements of the program that are appropriate for you, and take telephone surveys about your compliance with the program.

Study Visits:

On Day 1 of each cycle (before you receive paclitaxel), the following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your weight.
  • Your performance status will be recorded.
  • You will be asked about any drugs or treatments you may be receiving.
  • Blood (about 2-3 teaspoons) will be drawn for routine tests and tests of your prostatic specific antigen (PSA) and testosterone levels.
  • You will be asked about any side effects you may have experienced since your last visit.

On Days 8 and 15 of each cycle (before you receive paclitaxel), the following tests and procedures will be performed:

  • Your weight will be measured.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycle 3 and every 2 cycles thereafter, you will have the following tests and procedures performed:

  • You will have a chest x-ray and a CT scan of your abdomen and pelvis to check the status of the disease.
  • Blood (about 2 teaspoons) will be drawn to test your testosterone level and your liver function.
  • You will have a bone scan to check the status of the disease.
  • You will have an ECG.

If you are being treated with paclitaxel at your local oncologist's office, you are only required to return to M. D. Anderson on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle after that. All other study visits may be done at your local oncologist's office.

Length of Study:

You will continue on this study as long as you are benefiting. You will be removed from the study if you experience intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.

End-of-Study Visit:

Once you are off study, the following tests and procedures will be performed:

  • You will have a physical exam.
  • Blood (about 3-4 teaspoons) will be drawn for routine tests and tests of your PSA and testosterone levels.
  • You will be asked about any side effects you may have experienced since your last visit.
  • Your performance status will be recorded.

This is an investigational study. Lenalidomide is approved by the Food and Drug Administration (FDA) and commercially available for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. Paclitaxel is FDA-approved and commercially available for the treatment of bladder cancer, lung cancer, breast cancer, and pancreatic cancer. The use of these drugs in combination is investigational.

Up to 72 participants will take part in this study. All will be enrolled at M. D. Anderson.

Conditions
Prostate Cancer
Keywords
Castration-Resistant Prostate Cancer, CRPC, Prostate, Lenalidomide, Revlimid, CC-5103, Paclitaxel, Taxol, Taxanes
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, CC-5013

    Lead-In beginning dose of 5 mg capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28) for a 28 day cycle.

  • PaclitaxelDrug

    Also called Taxol

    50 mg/m^2 given by vein over 1 hour on Days 1, 8, and 15 of each 28 day cycle.

Study groups in NCT00933426
Study groupRoleWhat they receive
Lenalidomide and PaclitaxelExperimentalPhase I: Up to 5 differing doses of Lenalidomide tested plus fixed dose of Paclitaxel. Phase II: Lenalidomide at highest tolerated dose from Phase I plus Paclitaxel.
Receives: Drug: Lenalidomide; Drug: Paclitaxel

What is being measured

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

  1. Maximum tolerated dose (MTD) of Lenalidomide in Combination with Low-Dose Weekly Paclitaxel

    MTD defined as dose with posterior mean Pr{toxicity} closest to .33 at the end of the trial, provided that it is not terminated early. The CRM will be implemented using fixed toxicity probabilities (p1, p2, p3, p4, p5) = (.05, .20, .33, .45, .60) under the model Pr{toxicity | dose level j} = {pj}exp(a) , where a follows a normal prior with mean 0 and variance 2. Dose limiting toxicity (DLT) defined as any of the following treatment-related events occurring within two cycles of therapy (i) uncontrolled or intolerable grade 2 non-hematologic toxicity > 7 days, (ii) grade 3or 4 nausea/vomiting/diarrhea > 48 hours, (iii) > grade 3 fatigue > 7 days and any other grade 3or 4 non-hematologic toxicity; (iv) grade 4 hematologic toxicity (v) neutropenic fever defined as absolute neutrophil count (ANC) < 1000 and temperature >/ 101 degrees F; (vi) any other regimen-related adverse event that precludes delivery of the first two cycles of therapy.

    Measured: After 2, 28 day cycles

Secondary outcomes (1)

  1. Progression-Free (PFS) Time in Patients with a Lymph Node Dominant Clinical Phenotype

    The unadjusted PFS time distribution estimated using method of Kaplan and Meier. A Cox model or other appropriate time-to-event regression model, chosen based on preliminary goodness-of-fit analyses, used to assess the ability of either baseline or change during lead-in in biomarker status, as well as conventional covariates including performance status, hemoglobin and LDH, to predict PFS.

    13.0

    Measured: After 2, 28 day cycles

Timeline

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

  1. First posted7 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: Terminated early due to slow accrual as Phase I dose escalation study.

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933426
Sponsor's protocol ID
2008-0606
Other IDs
NCI-2010-01039
Status last verified
Oct 2016
First submitted
3 Jul 2009
Last updated
26 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide and Paclitaxel in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 17 inclusion and 13 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 26 Oct 2016. 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 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 was stopped early (reason given: Terminated early due to slow accrual as Phase I dose escalation study.). 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?

Maximum tolerated dose (MTD) of Lenalidomide in Combination with Low-Dose Weekly Paclitaxel (time frame: After 2, 28 day cycles). 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 NCT00933426.

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 26 Oct 2016.

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