ABI-008 Trial in Patients With Hormone-refractory Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Celgene Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00477529
First received: May 21, 2007
Last updated: April 6, 2012
Last verified: September 2010
  Purpose

To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008 given every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: ABI-008
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of ABI-008 (Nab-docetaxel) in Patients With Hormone-refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • DLT's and MTD's [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of ABI-008 in this patient population [ Time Frame: Q12 weeks and End of Study (EOS) and Follow Up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: April 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABI-008 Drug: ABI-008
nab-docetaxel
Other Name: nab-docetaxel

Detailed Description:

Detailed description not necessary.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study.

  1. Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is clinically refractory to hormone therapy.
  2. Zubrod Performance Status 0-1.
  3. 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.
  4. Patients must have demonstrated evidence of progressive disease since the most recent change in therapy. Progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression):

    • Measurable Disease Progression
    • Bone Scan Progression
    • PSA Progression
  5. Serum testosterone ≤ 50 ng/ml, determined within two weeks prior to starting treatment.
  6. Maintaining castrate status: Patients who have not undergone surgical orchiectomy should continue on medical therapies [e.g. gonadotropin releasing hormone analogs (GnRH analogs)] to maintain castrate levels of serum testosterone.
  7. Megestrol acetate (MEGACE®) treatment may continue if patient has been on stable doses of the drug.
  8. Age > 18 years of age.
  9. Four weeks since major surgery.
  10. The following restrictions on prior therapy for metastatic disease apply:

    • No prior chemotherapy regimen for metastatic disease.
    • No more than one prior course of palliative radiotherapy.
    • Up to one prior treatment with a non-chemotherapeutic agent (e.g., kinase inhibitors, immunotherapeutic agents, etc) is permitted as treatment for metastatic disease.
    • No prior radioisotope therapy with Strontium-89, Samarium or similar agents.
    • One prior neo-adjuvant or adjuvant chemotherapy regimen is permitted if given over 3 years ago.
  11. No limitation on prior hormonal therapy.
  12. Patients should be off all therapy for at least 4 weeks prior to study drug administration.
  13. Life expectancy should be ≥ 3 months.
  14. Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
  15. Required Initial Laboratory Data:

    • WBC ≥ 3,000/µl
    • ANC ≥ 1,500/µl
    • Platelet count ≥ 100,000/µl
    • Creatinine ≤ 1.5 x
    • Total Bilirubin ≤ (exceptions will be made for patients with Gilbert's Disease)
    • SGOT (AST) ≤ 1.5 x
    • SGPT (ALT) ≤ 1.5 x
  16. Men whose sexual partners are of child-bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of study participation.
  17. If obese (weight > 20% of ideal body weight) patient must be treated with doses calculated using adjusted BSA.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study.

  1. Patients may not be receiving any other investigational agents.
  2. Patients may continue on a daily Multi-Vitamin, low dose (≤ 400 IU qd) Vitamin D, Calcitrol (≤ 0.5 mcg qd), and calcium supplements, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration.
  3. Patients on stable doses of bisphosphonates, who develop subsequent tumor progression, may continue on this medication.However, patients may not initiate bisphosphonate therapy prior to or during study
  4. Patients with known brain metastases.
  5. Patients with history of allergic reactions attributed to solvent-based docetaxel (Taxotere).
  6. Patients with significant cardiovascular disease including congestive heart failure, active angina pectoris or recent myocardial infarction (within the last 6 months).
  7. Patients with a "currently active" second malignancy other than non-melanoma skin cancers.
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  9. HIV-positive patients receiving combination anti-retroviral therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477529

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: John C Araujo, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00477529     History of Changes
Other Study ID Numbers: CA301
Study First Received: May 21, 2007
Last Updated: April 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014