PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

NCT00313482 | Terminated Phase 2

• 1 other identifier: I-05-011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs:

• Docetaxel 75 mg/m2 IV given over 1 hour on Day 1.
• Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression.
• Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every 4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate the safety of this drug combination, patients will be evaluated at each clinic visit for adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE Version 3.0. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive a maximum of 10 cycles of treatment.

Conditions

Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the effects of the combination of docetaxel/prednisone with sargramostim on progression-free survival in chemotherapy-naïve male patients with hormone-refractory prostate cancer (HRPC).

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Secondary Outcomes (3)

• To evaluate the response (as demonstrated by PSA and/or measurable disease) to the combination of docetaxel/prednisone with sargramostim.

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• To evaluate the 1-year and 2-year survival following treatment with the combination of docetaxel/prednisone with sargramostim.

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• To evaluate the safety of the combination of docetaxel/prednisone with sargramostim.

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Interventions

Sargramostim DRUG

250 mcg/m2 SC days 2-15 of each cycle

Also known as: Leukine

Docetaxel DRUG

75 mg/m2 IV over 1 hour on Day 1 of each cycle

Also known as: Taxotere

Prednisone DRUG

5 mg orally BID on Day 1 continuously

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have signed an IRB-approved informed consent.
• Patients must be male with histologically confirmed metastatic adenocarcinoma of the prostate with progressive disease, despite androgen deprivation.
• Patients must have a history of prior hormone therapy (must fulfill one of the following criteria):
• Castration and/or luteinizing-hormone releasing hormone (LHRH) agonist
• Antiandrogen therapy (flutamide, nilutamide, bicalutamide, or cyproterone acetate)
• Antiandrogen therapy withdrawal
• Estramustine monotherapy
• Other hormonal therapy (eg, ketoconazole). Note: Patients must be off ketoconazole at least 1 month. If PSA is decreasing, the patient must demonstrate a rising PSA on at least 2 sequential reading at least 2 weeks apart.
• Patients must have a serum testosterone \<50 ng/dL (if the patient has not undergone orchiectomy, he must continue primary androgen deprivation with LHRH analogue).
• Patient must fulfill one of the following criteria:
• Patients with measurable disease:
• Patients must have disease progression defined by the RECIST criteria.
• Patients with no measurable disease:
• Patients with PSA only disease must have an elevated PSA by Consensus Criteria. -OR-
• Patients with a positive bone scan must also have elevated PSA defined by Consensus Criteria.

You may not qualify if:

• Prior systemic chemotherapy for the treatment of HRPC, with the exception of estramustine monotherapy.
• Prior treatment with ketoconazole, aminoglutethimide, or corticosteroids for the treatment of progressive prostate cancer.
• No prior immunotherapy with the exception of routine immunizations.
• Myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (New York Heart Association Class III or higher, see Appendix II) or uncontrolled cardiac arrhythmia.
• Patients with known HIV-positive status.
• Major surgery or radiation therapy \<4 weeks prior to enrollment.
• Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
• Patients with a history of severe hypersensitivity reaction to docetaxel, prednisone, sargramostim, yeast-derived products, other drugs formulated with polysorbate 80, or any of the components in these drugs.
• Patients with poorly controlled diabetes (fasting blood glucose \>250 mg/dL) despite optimization of medical therapy.
• Patients with serious uncontrolled intercurrent infections, nonmalignant medical illnesses, or active uncontrolled autoimmune disease. Note: suppressive antibiotic therapy for chronic urinary tract infections is allowed.
• Patients with a systemic fungal infection.
• Patients with psychiatric illness/social situations that would limit compliance with treatment or adequate informed consent.
• Any patient who is unable to comply with requirements of study.
• Patients with symptomatic peripheral neuropathy Grade \>2 (NCI Common Toxicity Criteria Version 3.0.
• Patients with known brain or leptomeningeal involvement.

Sponsors & Collaborators

• Veeda Oncology: lead
• Bayer: collaborator

Study Sites (1)

Veeda Oncology

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Interventions

sargramostim; Docetaxel; Prednisone

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Evan R Berger, MD

  North Shore Hematology Oncology Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

US (1)