Study of Trovax® Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer

NCT00521274 | Terminated Phase 2

• 2 other identifiers: HMRI IRB#0407-0036PCa-07-101
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the role of combination therapy with Trovax plus Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific antigen (PSA).

Conditions

Prostatic Neoplasms

Keywords

Progressive Hormone Refractory Prostate Cancer; HRPC; MVA 5T4; Trovax®; Docetaxel; M3thodist

Outcome Measures

Primary Outcomes (1)

• Time to PSA progression Safety: To compare adverse events, laboratory measurements and vital sign measurements between the treatment groups

  PSA measured every 6 weeks

Secondary Outcomes (1)

• PSA response rate Tumor response Overall survival

  PSA and tumor response measured every 6 weeks

Study Arms (2)

1

EXPERIMENTAL

Patients randomized to Arm 1 will receive treatment cycles of Docetaxel and vaccine. PI relocated, data not available.

Biological: MVA 5T4

2

ACTIVE COMPARATOR

Patients randomized to Arm 2 will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). PI relocated, data not available.

Drug: Docetaxel

Interventions

MVA 5T4 BIOLOGICAL

Docetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration.

Also known as: TroVax

1

Docetaxel DRUG

Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration.

Also known as: Taxotere

2

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate.
• Progressive disease after androgen deprivation.
• ECOG Status \< 2.
• No prior chemotherapy for prostate cancer therapy
• At least four weeks have lapsed since prior chemotherapy (if administered)
• Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
• Clinically immunocompetent.
• Free of clinically apparent/active autoimmune disease
• Absolute Lymphocyte Count ≥ 500/µl, ANC \>1200/µl, Platelet count \>100,000/µl, Hemoglobin \> 10 mg/dl, Peripheral neuropathy \<1.
• No evidence of active ischemia on ECG
• Age greater 18 years

You may not qualify if:

• Patients who have received prior chemotherapy.
• Patients receiving any other hormonal therapy, including any dose of megestrolacetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy.
• Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
• No supplements or complementary medicines/botanicals are permitted during the study, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements, Vitamin E
• Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment
• Major surgery or radiation therapy completed \< 4 weeks prior to enrollment.
• Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
• "Currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy more than 5 years previously and have no known evidence of residual or recurrent disease
• Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled.
• Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
• AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. The bilirubin must be within normal limits.
• Renal function creatinine ≥1.5 x ULN.
• Known allergy to egg proteins.
• Known allergy to neomycin.
• History of allergic response to previous vaccinia vaccinations.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Oxford BioMedica: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

TroVax; Docetaxel

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

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)