Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313534
• Other study ID #: CDR0000455645
• Secondary ID: UCSF-035510UCSF-
• Status: Terminated
• Phase: Phase 1
• First received: April 11, 2006
• Last updated: October 9, 2012
• Start date: June 2005
• Est. completion date: October 2006

Study information

• Verified date: October 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• masoprocol

Locations

Country	Name	City	State
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity as measured by CTC v3.0			Yes
Secondary	Maximum tolerated dose			Yes
Secondary	Prostate-specific antigen (PSA) at baseline and on day 1 of each course			No