Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

This study has been terminated.
(Ran out of drug)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00313534
First received: April 11, 2006
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: masoprocol
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Dose-limiting toxicity as measured by CTC v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Prostate-specific antigen (PSA) at baseline and on day 1 of each course [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.

Secondary

  • Determine prostate-specific antigen-modulating effects of NDGA in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of NDGA 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.

PROJECTED ACCRUAL: A total of 30 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 prostate cancer, meeting 1 of the following criteria:

    • Androgen-dependent disease (testosterone ≥ 250 ng/mL)
    • Androgen-independent disease (testosterone < 50 ng/mL)
  • Received prior definitive therapy for primary prostate cancer comprising any of the following:

    • External-beam radiotherapy with or without hormonal therapy
    • Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy
    • Radical prostatectomy with or without adjuvant or salvage radiotherapy
    • Cryotherapy
  • Must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (PSA) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart

    • Elevated PSA, meeting 1 of the following criteria:

      • At least 1.0 ng/mL post radiotherapy or cryotherapy
      • At least 4 ng/mL post radical prostatectomy
    • Must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation)
  • No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of abdomen/pelvis

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST ≤ 1.5 times ULN
  • No other medical condition that would interfere with study therapy or compliance
  • No other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at < 30% risk of relapse
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 8 weeks since prior strontium-chloride Sr 89
  • More than 4 weeks since first dose of bisphosphonates
  • More than 4 weeks since prior major surgery or radiotherapy
  • At least 4 weeks since prior hormonal agents, including megestrol or steroids

    • Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone
  • At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower PSA
  • Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met:

    • No more than 8 months of androgen deprivation
    • At least 12 months since last day of effective androgen deprivation
    • Testosterone > 250 ng/mL at enrollment
  • Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed
  • No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents
  • No concurrent radiotherapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  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: NCT00313534

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Charles Ryan, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00313534     History of Changes
Other Study ID Numbers: CDR0000455645, UCSF-035510, UCSF-H45860-23712-02A
Study First Received: April 11, 2006
Last Updated: October 9, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Nordihydroguaiaretic Acid
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antioxidants
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014