Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

NCT00521781 | Terminated Phase 2

• 2 other identifiers: HMRI IRB#0407-0035PCa-07-102
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.

Conditions

Prostatic Neoplasms

Keywords

Unresectable or Metastatic Adenocarcinoma Prostate Cancer; Hormonal Therapy; Abraxane; M3thodist

Outcome Measures

Primary Outcomes (1)

• Assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate.

  measurements every 4 wks while on Abraxane; then every 12 wks

Secondary Outcomes (1)

• Assess safety and tolerability of the study drug regimen. Overall survival Duration of response PSA "lead-time" to symptomatic or radiographic progression.

  AEs as occur

Study Arms (1)

1

EXPERIMENTAL

Treatment will be Abraxane/hormonal therapy (LHRH Agonist) for four nine-week cycles, followed by Total androgen blockade therapy (LHRH Agonist+ Anti-androgen) for 2 years from the time the hormonal therapy was started.

Drug: Abraxane; Drug: Leuprolide; Drug: Bicalutamide

Interventions

Abraxane DRUG

100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)

1

Leuprolide DRUG

7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years

Also known as: Depot Lupron®, LHRH agonist

1

Bicalutamide DRUG

50 mg p.o. daily starts week 36 of initiating Abraxane.

Also known as: Casodex®, Anti-androgen therapy

1

Eligibility Criteria

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

You may qualify if:

• Histologic proof of adenocarcinoma of the prostate.
• Patients must belong to one of four groups: 1) Local/Regional with prior definitive therapy: Patients with local/regional recurrence following prostatectomy or radiation therapy who still have a normal bone scan. 2) Local/Regional without prior definitive therapy: Patients felt to be unresectable, or are felt not to be candidates for, radiation therapy. 3) Low volume bone disease: Patients with 1 or 2 bone metastases. 4) High volume bone/visceral disease: Patients with ≥ 3 metastatic bone sites or visceral metastases.
• Patients meeting these criteria are eligible even without any radiographically demonstrable abnormality. All patients must have an elevated PSA prior to initial hormone exposure defined as: 1) For patients with prior prostatectomy, the PSA must be rising with an associated doubling time of ≤ 3 months. 2) For patients with prior radiation therapy, the PSA must be ≥ 1.0 ng/mL with an associated doubling time of ≤ 3 months. 3) For patients with the prostate in place, the PSA must be elevated with biopsy proven disease and are not candidates for local therapy.
• Patients may be on an LHRH agonist (with or without an anti-androgen), or already medically castrated, at the time of study entry, provided such therapy was started within 3 months of study entry.
• No previous cytotoxic systemic therapy of any kind is allowed, including systemic irradiation with strontium-89 and samarium. Previous definitive radiotherapy to one metastatic site is acceptable. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a single metastatic site are eligible 4 weeks following the completion of radiation.
• Patients may have had previous exposure to androgen deprivation therapy if it was given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed at least 12 months prior to entry into this study.
• Patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.
• Patients must have adequate physiologic reserves as evidenced by Zubrod Performance Status (ZPS) of ≤ 2, adequate bone marrow function, renal function and liver function and no evidence of active ischemia on ECG (if clinically indicated, documentation of EF ≥ 40%.)

You may not qualify if:

• Patients must not have a second malignancy unless there is confidence of previous curative therapy.
• Patients with a recent history of TIA (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible.
• Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
• Patients must not have Sensory neuropathy of grade 1 or greater.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Celgene Corporation: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; Leuprolide; Gonadotropin-Releasing Hormone; bicalutamide; Androgen Antagonists

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)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 28, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)