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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medical University of South Carolina.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00099086
First received: December 8, 2004
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

RATIONALE: 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.

PURPOSE: 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 Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: docetaxel
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Estimated Enrollment: 36
Study Start Date: July 2004
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of docetaxel, when given in combination with radiotherapy and hormonal therapy, in patients with high-risk clinically locally advanced prostate cancer.

Secondary

  • Determine progression-free survival and time to prostate-specific antigen failure in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of docetaxel.

Patients receive goserelin subcutaneously (SC) OR leuprolide intramuscularly (IM) once monthly AND oral bicalutamide once daily for 2 months. Patients then receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Concurrent with chemotherapy, patients undergo radiotherapy on days 1-5 weekly for 8.6 weeks (43 fractions). Patients continue to receive goserelin SC OR leuprolide IM once monthly during chemotherapy and radiotherapy and then every 3 months for 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually therafter.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Clinically locally advanced disease, defined as 1 of the following:

      • T_xN_0M_0 AND prostate-specific antigen (PSA) ≥ 20 ng/mL AND Gleason score ≥ 7
      • T_3b,4N_0M_0 AND any PSA and Gleason score
      • T_xN_0M_0 AND any PSA AND Gleason score ≥ 8
  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:

    • AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ ULN
    • AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
    • AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled cardiac disease

Other

  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No peripheral neuropathy > grade 1
  • No uncontrolled infection
  • No uncontrolled diabetes mellitus
  • No psychiatric illness that would preclude patient from giving informed consent
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for prostate cancer
  • No concurrent sargramostim (GM-CSF) or filgrastim (G-CSF)

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior androgen deprivation therapy allowed for up to 4 weeks before study entry
  • No concurrent hormone therapy except for the following:

    • Steroids for adrenal insufficiency
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
    • Intermittent dexamethasone as an antiemetic or as premedication for docetaxel administration

Radiotherapy

  • No prior radiotherapy for prostate cancer
  • No concurrent radiotherapy, including palliative radiotherapy

Surgery

  • At least 4 weeks since prior major surgery

Other

  • No prior alternative therapy for prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099086

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00099086     History of Changes
Other Study ID Numbers: CDR0000387959, MUSC-100783, MUSC-HR-11326, AVENTIS-MUSC-100783
Study First Received: December 8, 2004
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Docetaxel
Goserelin
Leuprolide
Androgen Antagonists
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014