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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

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

Adenocarcinoma of the prostate is the second leading cause of cancer death in men. Despite
rapid and often dramatic responses to androgen blockade, nearly all patients with metastatic
prostate cancer will develop androgen independent progression.(1) Unfortunately, to date no
single agent or combination therapy has been demonstrated to improve survival in patients
with metastatic androgen independent prostate cancer. The current standard of care, the
combination of mitoxantrone with corticosteroids, is palliative, and treatment with this
combination results in median survivals of 10 to 12 months. More recently, phase 2 studies
of docetaxel, either as a single agent or in combination with estramustine, demonstrated
median survivals of 20 to 23 months. Although docetaxel based therapy can potentially
increase the median survival from 12 to 20 months, new agents need to be identified to
further extend survival.

Lenalidomide is a member of a class of pharmaceutical compounds known as immunomodulatory
drugs (IMiDs™). The first clinically available IMiD, thalidomide (Thalomide), has
demonstrated activity against a variety of solid tumors as well as hematological
malignances. A potentially greater potency to activate immunomodulatory effects is a major
advantage of lenalidomide compared to thalidomide. Three in vitro studies have been
performed to compare the activity and potency of lenalidomide and thalidomide. Two studies
examined the effects of lenalidomide or thalidomide on the production of various cytokines
and the other examined effects on multiple myeloma cell proliferation. In all studies,
lenalidomide was approximately 50 to 2000 times more potent than thalidomide.

Inclusion Criteria:

- 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

- 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.

- 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

- 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

Exclusion Criteria:

- 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.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of lenalidomide and docetaxel given every three weeks with prednisone

Outcome Time Frame:

Until disease progression

Safety Issue:


Principal Investigator

Daniel P Petrylak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

November 2012

Related Keywords:

  • Prostate Cancer
  • Androgen Independent Prostate Cancer
  • Prostatic Neoplasms



Columbia University Medical CenterNew York, New York  10032
Cornell Weill Medical CenterNew York, New York  10065