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Breast Cancer

Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer (UW07003)
A Phase I Study Evaluating a Second Generation Antisense Oligonucleotide (OGX-427) that Inhibits Heat Shock Protein 27 (Hsp 27)
Status Conditions Phase Study ID
Recruiting Bladder Cancer; Breast Cancer; Genitourinary Cancer; Gynecological Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Solid Tumors Phase I 20070773
NCT00487786
Summary
The purpose of this study is to determine the safety and effects (both good and bad) of an experimental drug called OGX-427 in patients with prostate, ovary, breast, bladder or non-small cell lung cancer which has spread to other places in the body (metastatic cancer).

In this study we will try to find the the highest dose of OGX-427 that does not cause intolerable side effects (the maximum tolerated dose).

After finding the maximum tolerated dose, we will study the safety and effects (both good and bad) of OGX-427 when taken in combination with a chemotherapy drug called docetaxel.

Not all participants enrolled in this study will receive docetaxel.

The study drug, OGX-427, is given as an infusion through a vein in the arm about once a week. Treatment with OGX-427 will continue for about 2 – 9 months, depending on the participant’s medical condition.

Participants in this study will receive the study drug, OGX-427, at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).

After treatment has stopped, we would like to follow-up with study participants every 2 months.


Investigator
Evan Yu, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

1. Age 18 years or older.

2. Diagnosis of one of the following:

• Breast cancer

• Prostate cancer

• Ovarian cancer

• Non-small cell lung cancer (NSCL)

• Bladder cancer

 

 

3. Previous treatment has not been successful, or no treatment exists for the cancer.

 

 

4. Disease has spread beyond the original location (metastatic cancer).

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• More than three cytotoxic chemotherapy regimens. (This does not include immunotherapy, non-cytotoxic experimental therapy, radiation therapy, hormone or estrogen therapy, steroids, tamoxifen and/or aromatase inhibitors).

• Current treatment with any anticancer agent including (but not limited to) trastuzumab, aromatase inhibitors, or tamoxifen. Steroids, bisphosphonates and female hormone-replacement therapy are allowed.

• Documented central nervous system (CNS) metastasis or carcinomatous meningitis.

• Pregnancy or breastfeeding.

• Current second malignancy except for non-melanoma skin cancers, superficial bladder cancer, early cervical cancer or early prostate cancer not requiring treatment.

Other exclusion criteria may apply.

Last Updated
April 12, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.