Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

NCT00527124 | Terminated Phase 2 Results DMC

• 8 other identifiers: NCI-2009-001742007-015CDR00005644497451N01CM00038U01CA062491P30CA022453U01CA062487
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

Brief Summary

This randomized phase II trial is studying how well giving docetaxel and prednisone together with or without cediranib works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel together with prednisone, with or without cediranib, may kill more tumor cells.

Conditions

Adenocarcinoma of the Prostate; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month Progression-free Survival (PFS) Proportion

  The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free

  Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months

Secondary Outcomes (4)

• Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group

  Up to 52 weeks

• Overall Response Rate Evaluated by the RECIST Criteria

  Up to 52 weeks

• Time to Progression

  The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks

• Overall Survival

  The time from registration date until death from any cause, assessed up to 52 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.

Drug: cediranib maleate; Drug: docetaxel; Drug: prednisone; Other: laboratory biomarker analysis

Arm II

ACTIVE COMPARATOR

Patients receive docetaxel and prednisone as in arm I.

Drug: docetaxel; Drug: prednisone; Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

cediranib maleate DRUG

Given orally

Also known as: AZD2171, Recentin

Arm I

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Arm I; Arm II

prednisone DRUG

Given orally

Also known as: DeCortin, Deltra

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Clinical/radiologic metastases with objective evidence of disease progression by imaging or by rising prostate-specific antigen (PSA) despite androgen deprivation therapy
• Rising PSA must be determined based on a rising trend with 2 successive elevations at a minimum interval of 1 week
• Meets 1 of the following criteria: Measurable disease, with any level of PSA, at least 1 unidimensionally measurable lesion (longest diameter to be recorded) \>= 20 mm by conventional techniques or \>= 10 mm by spiral CT scan, nonmeasurable disease, PSA \>= 5 ng/mL OR new areas of bony metastases on bone scan
• Castrate levels of testosterone \< 50 ng/dL must be maintained and documented
• Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone
• Total bilirubin normal
• Patients with radiological evidence of stable brain metastases are eligible provided they are asymptomatic and do not require corticosteroids or have been treated with corticosteroids and show clinical and radiological evidence of stabilization at least 10 days after discontinuation of steroids
• ECOG performance status (PS) =\< 2 or Karnofsky PS 60-100%
• Life expectancy \> 12 weeks
• Leukocytes \>= 3,000/mcL
• Absolute neutrophil count \>= 1,500/mcL
• Platelet count \>= 100,000/mcL
• Histologically confirmed adenocarcinoma of the prostate
• AST and ALT =\< 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance \>= 60 mL/min

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cediranib; Docetaxel; Prednisone

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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Closure was recommended by CTEP due to slow accrual.

Results Point of Contact

• Title: Elisabeth I. Heath
• Organization: Barbara Ann Karmanos Cancer Institute

heathe@karmanos.org

313-576-8715

Study Officials

• Elisabeth Heath

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2013
• Last Updated: August 9, 2018
• Results First Posted: March 11, 2014

Record last verified: 2018-07

Locations

US (4)