Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

NCT00005028 | Completed Phase 2

• 3 other identifiers: MSGCC-9948CDR0000067549NCI-50
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: bryostatin 1; Drug: paclitaxel

Interventions

bryostatin 1 DRUG

Arm I

paclitaxel DRUG

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate that failed first- or second-line hormonal therapy (e.g., gonadal androgen suppression \[orchiectomy or luteinizing hormone-releasing hormone\] with or without antiandrogens) * Failure on hormonal therapy is defined by 1 of the following criteria: * Biochemical progression (after withdrawal of antiandrogens), documented by 3 rising PSA values, each value measured at least 2 weeks apart, with the last measurement being at least 25% of the nadir achieved while on hormonal therapy and with an increase in the absolute value by at least 5 ng/mL * Measurable disease progression, defined by an increase in the sum of the products of the perpendicular diameters of any measurable lesion(s) by at least 25% * Bone only progression allowed only with concurrent biochemical progression * Castrate levels of testosterone (no greater than 50 ng/dL) * No clinical signs/symptoms suggesting CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 times ULN * Calcium no greater than ULN Cardiovascular * No uncontrolled or severe cardiovascular disease * No myocardial infarction within the past 6 months * No congestive heart failure * No angina pectoris * No active thromboembolic events within the past 3 months (e.g., deep venous thrombosis or cerebrovascular accident) Other * No other serious medical or psychiatric illness * No active infection * No dementia or significantly altered mental status * No prior or concurrent grade 1 or greater peripheral neuropathy * No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer * HIV negative * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy (including paclitaxel) Endocrine therapy * At least 4 weeks since prior steroids or megestrol Radiotherapy * At least 4 weeks since prior radiotherapy to bone lesions Other * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Wellspan Health - York Cancer Center

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bryostatin 1; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Arif Hussain, MD

  University of Maryland Greenebaum Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: March 7, 2003
• Study Start: May 1, 2000
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

US (4)