Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

Sponsor

Medical University of South Carolina (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00099086

Collaborator

(none)

Enrollment

Arm

191.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Bicalutamide Drug: docetaxel Drug: GnRh analog Radiation: radiotherapy	Phase 1

Detailed Description

Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer

Actual Study Start Date :

Jan 16, 2007

Actual Primary Completion Date :

Jan 20, 2011

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm	Drug: Bicalutamide Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Other Names: Casodex Drug: docetaxel Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2 Other Names: Taxotere Drug: GnRh analog A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Other Names: Zoladex goserelin acetate leuprolide acetate Lupron Radiation: radiotherapy External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.

Arm

Intervention/Treatment

Experimental: Experimental Arm

Drug: Bicalutamide

Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Other Names:

Casodex

Drug: docetaxel

Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2

Other Names:

Taxotere

Drug: GnRh analog

A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Other Names:

Zoladex

goserelin acetate

leuprolide acetate

Lupron

Radiation: radiotherapy

External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy [57 days]
To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
Performance status 0-2
Must meet criteria for acceptable lab values as outlined in the protocol.
Peripheral neuropathy must be greater than or equal to 1
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.