A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Treatments: Docetaxel; Hormones

Criteria

Inclusion Criteria:

• 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 at least 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 1000,000 per cubic millimeter.

• A total bilirubin not grater 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

Exclusion Criteria:

• 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