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Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
This study has been terminated.
First Received: February 8, 2005   Last Updated: January 31, 2006   History of Changes
Sponsored by: Cell Genesys
Information provided by: Cell Genesys
ClinicalTrials.gov Identifier: NCT00103428
  Purpose

V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.

All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.


Condition Intervention Phase
Prostate Cancer
Biological: CG7870
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • Metastatic hormone refractory prostate cancer

Estimated Enrollment: 69
Study Start Date: August 2004
  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
  • Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
  • ECOG performance status 0-1

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • History of deep vein thrombosis or pulmonary embolus
  • Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
  • History of a bleeding disorder or recent clinically significant bleeding
  • Seropositive for HIV
  • History of Hepatitis B, Hepatitis C, or chronic liver disease
  • Prior gene therapy or immunotherapy
  • Prior chemotherapy for prostate cancer
  • Radiation therapy within 4 weeks of the first treatment.
  • History of myocardial infarction within 6 months of the first treatment
  • History of cerebrovascular accident
  • History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
  • Evidence of active prostatitis
  • Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103428

Locations
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Cell Genesys
  More Information

No publications provided

Study ID Numbers: V-0039
Study First Received: February 8, 2005
Last Updated: January 31, 2006
ClinicalTrials.gov Identifier: NCT00103428     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Genesys:
chemotherapy
prostate cancer
cancer
metastatic
hormone refractory
chemotherapy naive
dose escalation

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009