RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
This study has been terminated.
(Low overall response rate)
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00630344
First received: February 28, 2008
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: RAD001 Drug: Bicalutamide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the best overall response and duration of response, taking into consideration measurable disease, bone metastases and PSA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To characterize the toxicity profile of RAD001 in combination with standard dose bicalutamide in patients with androgen independent prostate cancer. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 36 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: RAD001
Taken orally once daily
Drug: Bicalutamide
Taken orally once daily
- Participants will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks during which time participants will take RAD001 and bicalutamide orally, once per day. RAD001 will be provided from the research pharmacy at the hospital and a prescription will be given for bicalutamide to obtain from a local pharmacy.
- A history, physical exam, and blood tests will be performed every four weeks. An assessment of the tumor by Chest CT scan, chest x-ray, bone scan, and abdomen/pelvis CT or MRI will be performed every 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older
- Histologically documented prostate cancer
- Castration resistant prostate cancer defined as two rising PSAs on castration therapy
- Baseline PSA of 2ns/mL or greater
- Testosterone of 50ng/mL or less
- Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
- Prior bicalutamide is allowed as long as treatment was for 6 months or longer
- Metastatic disease is not required
- Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- ECOG Performance Status equal to or less than 2
- Adequate bone marrow and liver function as outlined by parameters in the protocol
Exclusion Criteria:
- Prior treatment with any investigational drug within the preceding 4 weeks
- Prior treatment with an mTOR inhibitor
- Fasting lipids over the parameters outlined in the protocol
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
- Men able to conceive and unwilling to practice an effective method of birth control
- Known hypersensitivity to RAD001 or other rapamycins or to its excipients
- History of noncompliance to medical regimens
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630344
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Investigators
| Study Chair: | Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Mary-Ellen Taplin, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00630344 History of Changes |
| Other Study ID Numbers: | 07-316 |
| Study First Received: | February 28, 2008 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
RAD001 bicalutamide androgen independent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Sirolimus Everolimus Bicalutamide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Anti-Bacterial Agents Androgen Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013