The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

NCT ID: NCT00459186

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).

Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).

Detailed Description

• Patients will be designated into one of two groups based upon the results of a FDG-PET scan.
• A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks. On day 10-14, another FDG-PET scan and serum assessment will be performed. An optional bone marrow biopsy may also be done. On day 15, patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II.
• A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling.
• Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks.
• Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks.
• The maximum duration of the trial is one year of therapy.

Conditions

Metastatic, Androgen Independent Prostate Cancer; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAD001 Followed by RAD001 + Docetaxel

RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.

Group Type: EXPERIMENTAL

RAD001

Intervention Type: DRUG

Daily for two weeks

Docetaxel

Intervention Type: DRUG

Infusion once per cycle

Prednisone

Intervention Type: DRUG

Prednisone 5 mg by mouth twice daily

Interventions

RAD001

Daily for two weeks

Intervention Type: DRUG

Docetaxel

Infusion once per cycle

Intervention Type: DRUG

Prednisone

Prednisone 5 mg by mouth twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adenocarcinoma of the prostate with radiographic evidence of metastatic disease.
• Willingness to undergo a baseline tumor biopsy.
• Castrate levels of testosterone (testosterone < 50 ng/dL) on androgen deprivation therapy (ADT) with evidence of progression on ADT. GnRH therapy will be continued for those on it at baseline
• Patient must have suspected tumor in an area that is safe to biopsy.
• Other prior hormonal interventions or experimental approaches are allowed. These therapies must have been discontinued for a minimum of 28 days with cancer progression.
• Prior or concurrent use of bisphosphonates is allowed.
• One prior non-taxane chemotherapy allowed
• ≥ 3 weeks since major surgery; ≥ 4 weeks since radiotherapy; ≥ 8 weeks since prior strontium-89 or samarium 153
• Performance Status: ECOG 0 or 1
• ANC > 1,500/_l; platelets > 100,000/_l; total Bilirubin < upper limit of normal; AST and ALT < 3 x upper limits of normal; creatinine < 1.5 x upper limits of normal; total fasting cholesterol < 350 mg/dl; total triglycerides < 300 mg/dl

Exclusion Criteria

• Ongoing oral steroid use. Patients with a history of oral steroid use are eligible as long as the steroids have been discontinued prior to study entry. Ongoing topical and/or inhaled steroid use is allowed.
• Prior taxane chemotherapy
• Prior mTOR inhibitors (RAD001, rapamycin, CCI-779)
• Currently active second malignancy other than non-melanoma skin cancer.
• Ongoing peripheral neuropathy of Grade 2

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary-Ellen Taplin, MD

Associate Professor of Medicine, HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Oregon Health Science University

Portland, Oregon, United States

Countries

United States

References

Courtney KD, Manola JB, Elfiky AA, Ross R, Oh WK, Yap JT, Van den Abbeele AD, Ryan CW, Beer TM, Loda M, Priolo C, Kantoff P, Taplin ME. A phase I study of everolimus and docetaxel in patients with castration-resistant prostate cancer. Clin Genitourin Cancer. 2015 Apr;13(2):113-23. doi: 10.1016/j.clgc.2014.08.007. Epub 2014 Oct 22.

Reference Type: DERIVED

PMID: 25450031 (View on PubMed)

Other Identifiers

05-184

Identifier Type: -

Identifier Source: org_study_id