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A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Metastatic hormone refractory prostate cancer

Authority:

United States: Food and Drug Administration

Study ID:

V-0039

NCT ID:

NCT00103428

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • chemotherapy
  • prostate cancer
  • cancer
  • metastatic
  • hormone refractory
  • chemotherapy naive
  • dose escalation
  • Prostatic Neoplasms

Name

Location

Mary Crowley Medical Research CenterDallas, Texas  75246