A study to evaluate the effect of immunoadjuvant therapy with Mycobacterium w and Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2007/091/000033
- Lead Sponsor
- Cadila Pharmaceuticals ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 176
§:Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
§:Disease progression during antiandrogen therapy, having surgical or medical castration status.
§:Karnofsky Performance Status 50-100
§:Normal cardiac function.
§:Life expectancy atleast 24 weeks
§:Laboratory criteria for eligibility will include
§:A neutrophil count of at least 1500 per cubic millimeter,
§:A hemoglobin level of at least 9 gm%,
§:A platelet count of at least 100,000 per cubic millimeter,
§:A total bilirubin not greater than 1.5 times the upper limit of the normal range for each institution,
§:Serum creatinine levels not more than 1.5 times the upper limit of the normal range.
§:Written informed consent.
§:Prior treatment with cytotoxic agents or radioisotopes.
§:Estrogen use for at least three months.
§:History of another cancer within the preceding five years (except basal or squamous-cell skin cancer).
§:Brain or leptomeningeal metastases.
§:Symptomatic peripheral neuropathy of grade 2 or higher.
§:Uncontrolled intercurrent illness that would limit compliance with study requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method