Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

NCT00460031 | Completed Phase 2 Results DMC

• 1 other identifier: CASE12805
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone together with lenalidomide works in treating patients with prostate cancer that did not respond to hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease

  Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) \>= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.

  28 days

Secondary Outcomes (4)

• Time to Progression

  One year (12 months) after start of treatment

• Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0

  Up to 30 days after discontinuation of treatment

• Change in Immune Response From Baseline

  Week 8

• Ratio of Change in Immune Response From Baseline

  Week 8

Study Arms (1)

Ketoconazole Plus Lenalidomide

EXPERIMENTAL

Drug: ketoconazole; Drug: lenalidomide; Drug: therapeutic hydrocortisone

Interventions

ketoconazole DRUG

400 tid

Also known as: held for toxicity, missed days of therapy are not made up.

Ketoconazole Plus Lenalidomide

lenalidomide DRUG

Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.

Ketoconazole Plus Lenalidomide

therapeutic hydrocortisone DRUG

20mg qam 10mg qhs

Ketoconazole Plus Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Progressive disease after androgen deprivation.

You may not qualify if:

• Prior ketoconazole, aminoglutethimide or corticosteroids for the treatment of progressive prostate cancer.
• Prior immunotherapy including, but not limited to, vaccines, Thalidomide, and or Lenalidomide like agents.
• Supplements or complementary medicines/botanicals are not permitted while on protocol therapy, except for any combination of the following:
• conventional multivitamin supplements selenium lycopene soy supplements Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment Serious intercurrent infections or non-malignant medical illnesses including autoimmune disorders that are uncontrolled.
• Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
• Evidence of CNS (brain or Leptomeningeal) metastases or large pleural/pericardial effusions.
• Known contraindication to receive Ketoconazole or Lenalidomide Concurrent use of ketoconazole with statin compounds is absolutely contraindicated. Thus, patients receiving Statin drugs (fluvastatin, atorvastatin, and simvastatin) should discontinue them for at least 7 days before starting ketoconazole.
• Patients taking astemizole, terfenadine, or cisapride, rifampin or isoniazid are not eligible, unless they agreed to completely discontinue those agents. In that case, any of these agents should be discontinued at least 7 days prior to start therapy with Ketoconazole.
• Use of any other experimental drug or therapy within 28 days of baseline. Known hypersensitivity to thalidomide or its analogues. Any prior use of Lenalidomide. Known positive for HIV or infectious hepatitis, type A, B or C. Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the breast.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (6)

Lake/University Seidman Cancer Center

Cleveland, Ohio, 44060, United States

Location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44121, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Barata PC, Cooney M, Mendiratta P, Tyler A, Dreicer R, Garcia JA. Ketoconazole plus Lenalidomide in patients with Castration-Resistant Prostate Cancer (CRPC): results of an open-label phase II study. Invest New Drugs. 2018 Dec;36(6):1085-1092. doi: 10.1007/s10637-018-0660-3. Epub 2018 Sep 6.

  PMID: 30191523 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ketoconazole; 1-methyl-4-(1-naphthylvinyl)piperidine; Lenalidomide; Hydrocortisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge Garcia, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Matthew M. Cooney, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: September 1, 2006
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: July 24, 2020
• Results First Posted: December 9, 2015

Record last verified: 2020-07

Locations

US (6)