Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

NCT00459810 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000540438OHSU-2656
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%

  PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.

  While receiving study agents (on average, 3 months)

Secondary Outcomes (4)

• Measurable Disease Response Rate (Soft Tissue)

  While receiving study agents (on average, 3 months)

• Time to Disease Progression

  At time of progression by PSA or RECIST criteria

• Time to Death

  Measured at Date of Death from any cause

• Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response

  Measured after 4 cycles of combination therapy

Interventions

transdermal estradiol DRUG

Transdermal estradiol given 0.2mg/day for duration of study.

paclitaxel poliglumex DRUG

Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Stage IV disease * Radiographic evidence of regional or distant metastases * Evidence of disease progression (by PSA and/or imaging studies) despite standard hormonal therapy and after exposure to docetaxel-containing chemotherapy, as evidenced by any of the following: * Measurable or evaluable disease progression, defined as the appearance of new lesion(s) or unequivocal increase in previously existing lesions or masses * Disease progression by PSA\*, defined by 1 of the following: * 3 consecutively rising PSA with the second PSA taken ≥ 1 week after the first PSA * 2 consecutively rising PSA with a fourth PSA \> the second PSA NOTE: \*The last required PSA must be after the required antiandrogen washout period for patients who have been on antiandrogen therapy * Must have received prior therapy with at least two 3-weekly doses or six weekly doses of docetaxel * Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons * Prior treatment with combinations of docetaxel with estramustine phosphate sodium or noncytotoxic agents (biologic agents) allowed * Serum testosterone \< 50 ng/dL (unless surgically castrate) * Patients must continue androgen deprivation with a luteinizing hormone-releasing hormone agonist if they have not undergone orchiectomy * No known or suspected brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * No other active malignancy except adequately treated nonmelanoma skin cancer or other noninvasive or in situ neoplasm * No other significant active medical illness or infection that would preclude study compliance * No significant cardiovascular illness, including any of the following: * NYHA class III or IV congestive heart failure * Unstable angina * Myocardial infarction within the past 6 months * Acute deep venous thrombosis * Acute pulmonary embolism * No significant peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 weeks since prior antiandrogen therapy (4 weeks for flutamide) * No current evidence of an antiandrogen withdrawal response * More than 4 weeks since prior radiotherapy * More than 8 weeks since prior radiopharmaceutical therapy (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) * No prior paclitaxel * No other concurrent cytotoxic agents * No other concurrent chemotherapy or biologic response modifiers * No concurrent supplements known or suspected to contain supplemental estrogens

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

paclitaxel poliglumex

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Coordinator
• Organization: Oregon Health & Science University Knight Cancer Institute

eilersk@ohsu.edu

(503) 494-2897

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: June 23, 2010

Record last verified: 2017-04

Locations

US (2)