Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

NCT00017563 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000068719OHSU-2794OHSU-HOR-00037-LNCI-G01-1962
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.

  Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA \> 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.

  Every 3 months after surgery for up to 5 years.

Study Arms (1)

Docetaxel, Mitoxantrone, Conventional Surgery

EXPERIMENTAL

Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy

Drug: docetaxel; Drug: mitoxantrone hydrochloride; Procedure: conventional surgery

Interventions

docetaxel DRUG

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Docetaxel, Mitoxantrone, Conventional Surgery

mitoxantrone hydrochloride DRUG

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Docetaxel, Mitoxantrone, Conventional Surgery

conventional surgery PROCEDURE

Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.

Docetaxel, Mitoxantrone, Conventional Surgery

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 * High-risk, as defined by 1 of the following: * Stage T2b (palpable bilateral involvement) or surgically resectable T3 * PSA 15 ng/mL or greater * Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4) * At least a 50% chance of prostate cancer recurrence within 5 years * Planned prostatectomy as primary therapy * No evidence of bone metastases by bone scan * No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan (scan required only if PSA greater than 40 ng/mL) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group(ECOG) 0-2 Life expectancy: * At least 10 years Hematopoietic: * White Blood Cell(WBC) at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Conjugated bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 4 times ULN * Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN) Renal: * Not specified Cardiovascular: * Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan Other: * No other malignancy within the past 5 years except nonmelanoma skin cancer * No significant active medical illness that would preclude study therapy * No peripheral neuropathy grade 2 or greater * No hypersensitivity to drugs formulated with polysorbate-80 * No significant contraindications to corticosteroids PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy * No other concurrent cytotoxic chemotherapy Endocrine therapy: * No prior or concurrent conventional hormonal therapy Radiotherapy: * No prior or concurrent radiotherapy (external beam or brachytherapy) Surgery: * See Disease Characteristics Other: * No prior or concurrent cryotherapy

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)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Mitoxantrone

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; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Quinones; Polycyclic Compounds

Results Point of Contact

• Title: Tomasz Beer, M.D.
• Organization: OHSU Knight Cancer Institute

beert@ohsu.edu

503-494-1080

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 6, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Primary Completion: May 1, 2010
• Last Updated: April 28, 2017
• Results First Posted: August 31, 2011

Record last verified: 2017-04

Locations

US (2)