Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

NCT00587431 | Completed Phase 2 Results

• 1 other identifier: 03-076
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Docetaxel; 03-076

Outcome Measures

Primary Outcomes (1)

• PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy

  Conclusion of the study (at 6 months then at 18 months post-treatment)

Secondary Outcomes (1)

• The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.

  at Cycle 1 and 2

Study Arms (2)

1

EXPERIMENTAL

Drug: GnRh (Leuprolide); Drug: Testosterone Gel; Drug: Docetaxel

2

ACTIVE COMPARATOR

Drug: GnRh (Leuprolide); Drug: Testosterone Gel

Interventions

GnRh (Leuprolide) DRUG

Leuprolide LUPRON

Also known as: 22.5 mg intramuscular injection

1; 2

Testosterone Gel DRUG

Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)

Also known as: AndroGel

1; 2

Docetaxel DRUG

70 mg/m2 given on day o1 of each 3 week cycle

Also known as: Taxotere

1

Eligibility Criteria

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

You may qualify if:

• Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
• Patient must have a serum testosterone \> 180 ng/dl.
• Karnofsky performance status (KPS)\>\_70%.
• Patients must have adequate organ function as defined by the following
• laboratory criteria:
• WBC \>\_ 3500/mm3
• ANC \>\_1500/mm3
• Platelet count \>100,000/mm3
• Hemoglobin \>8.0g/dL
• Creatinine \<1.6mg/dl
• Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
• SGOT and SGPT If alkaline phosphatase is \_\< 2.5 x ULN, any elevations in
• AST/ALT; OR if AST/ALT is \_\<1.5 x ULN, any elevation in alkaline phos
• Prior hormonal therapy is allowed as:
• Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).

You may not qualify if:

• Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• Uncontrolled serious active infection.
• Anticipated survival of less than 3 months.
• Active CNS or epiduraltumor
• Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
• Peripheral neuropathy \>\_ grade 3.
• Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
• Prior chemotherapy
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Leuprolide; Injections, Intramuscular; Testosterone; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Dana Rathkopf
• Organization: Memorial Sloan-Kettering Cancer Center

rathkopd@mskcc.org

646-422-4379

Study Officials

• Dana Rathkopf, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: July 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 7, 2023
• Results First Posted: August 21, 2014

Record last verified: 2023-10

Locations

US (1)