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

NCT00110214 | Completed Phase 3 Results

• 5 other identifiers: NCI-2012-02814CDR0000427290CALGB-90401P30CA014236U10CA031946
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.

  Duration of study (up to 5 years)

Secondary Outcomes (3)

• Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline

  Duration of study (up to 5 years)

• Progression-free Survival (PFS)

  Duration of study (up to 5 years)

• Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities

  During treatment (up to 2 years)

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21.

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

Arm II

EXPERIMENTAL

Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.

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

Interventions

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Arm I; Arm II

placebo OTHER

Given IV

Also known as: PLCB

Arm I

prednisone DRUG

Given orally

Also known as: DeCortin, Deltra

Arm I; Arm II

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm II

laboratory biomarker analysis OTHER

Correlative studies

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:

• Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (clinically metastatic disease documented on bone, CT or MRI scan) disease despite castrate levels of testosterone due to orchiectomy or LHRH agonist; castrate levels of testosterone must be maintained
• All eligible patients must have a Gleason sum based on biopsy or TURP at the time of registration
• At the time of enrollment, patients must have evidence of progressive metastatic disease, either:
• Measurable disease with any level of serum PSA OR
• Non-measurable disease with PSA ≥ 5 ng/ml; patients with PSA ≥ 5 ng/ml only and no other radiographic evidence of metastatic prostate cancer are not eligible
• Definition of Measurable Disease/Target Lesions:
• Any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques: 1) physical exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest X-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as ≥ 10 mm with a spiral CT or MRI scan
• Measurable lesions (up to a maximum of 10 in number) representative of all organs involved to be identified as target lesions; the sum of the longest diameters (LD) for all target lesions will be calculated and reported as baseline sum LD
• If measurable disease is confined to a solitary lesion and is not consistent with prostate cancer, then its neoplastic nature must be confirmed by histology
• Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically
• Definition of Non-measurable Disease/Non-target Lesions:
• Non-target lesions include all other lesions not included in above, including small lesions with longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan and truly non-measurable lesions, which include:
• Bone lesions
• Pleural or pericardial effusions, ascites
• CNS lesions, leptomeningeal disease

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Related Publications (3)

• Quintanilha JCF, Kelly WK, Innocenti F. Contribution of plasma levels of VEGF-A and angiopoietin-2 in addition to a genetic variant in KCNAB1 to predict the risk of bevacizumab-induced hypertension. Pharmacogenomics J. 2024 Jul 12;24(4):22. doi: 10.1038/s41397-024-00342-1.

  PMID: 38992025 DERIVED

• Quintanilha JCF, Wang J, Sibley AB, Jiang C, Etheridge AS, Shen F, Jiang G, Mulkey F, Patel JN, Hertz DL, Dees EC, McLeod HL, Bertagnolli M, Rugo H, Kindler HL, Kelly WK, Ratain MJ, Kroetz DL, Owzar K, Schneider BP, Lin D, Innocenti F. Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients. Br J Cancer. 2022 Feb;126(2):265-274. doi: 10.1038/s41416-021-01557-w. Epub 2021 Oct 6.

  PMID: 34616010 DERIVED

• Quintanilha JCF, Liu Y, Etheridge AS, Yazdani A, Kindler HL, Kelly WK, Nixon AB, Innocenti F. Plasma levels of angiopoietin-2, VEGF-A, and VCAM-1 as markers of bevacizumab-induced hypertension: CALGB 80303 and 90401 (Alliance). Angiogenesis. 2022 Feb;25(1):47-55. doi: 10.1007/s10456-021-09799-1. Epub 2021 May 24.

  PMID: 34028627 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; Bevacizumab

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: William Kevin Kelly, DO
• Organization: Thomas Jefferson University

wm.kevin.kelly@jefferson.edu

Study Officials

• William Kelly

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2005
• First Posted: May 5, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2011
• Last Updated: May 9, 2014
• Results First Posted: April 17, 2013

Record last verified: 2012-12

Locations

US (2)