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

NCT00525408 | Terminated Phase 2 DMC

• 1 other identifier: CR-60/1260
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

HRPC; Metastatic Hormone Refractory Prostate Cancer; Docetaxel; Mycobacterium w

Outcome Measures

Primary Outcomes (2)

• Median Survival time

  12 months

• Time to Tumor Progression

  12 Months

Secondary Outcomes (1)

• hematological toxicity, PSA levels, Quality of Life

  12 months

Study Arms (2)

2

EXPERIMENTAL

Docetaxel+Mw

Biological: Mycobacterium w.

1

ACTIVE COMPARATOR

Docetaxel

Drug: Docetaxel

Interventions

Mycobacterium w. BIOLOGICAL

Immunomodulator

2

Docetaxel DRUG

Chemotherapeutic agent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (14)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Kasturba Hospital,

Manipal, Karnataka, 576104, India

Location

Regional Cancer Centre

Trivandrum, Kerala, 695011, India

Location

Choithram Hospital & Research Centre

Indore, Madhya Pradesh, 452014, India

Location

Seth G.S. Medical College & KEM Hospital

Pārel, Mumbai, 400012, India

Location

Lokmanya Tilak Municipal Medical College & General Hospital

Sion, Mumbai, 400022, India

Location

V.M. Medical College & Safdarjang Hospital

New Delhi, National Capital Territory of Delhi, India

Location

Rajiv Gandhi Cancer Institute & Research Center

Rohini, National Capital Territory of Delhi, 110085, India

Location

Patel Hospital Pvt. Ltd.

Jalandhar, Punjab, 144001, India

Location

Christian Medical College, Ludhiana

Ludhiana, Punjab, 141008, India

Location

S.P. Medical College & A. G. of Hospitals

Bikaner, Rajashthan, 334003, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632002, India

Location

Chatrapati Sahuji Mahraj Medical University

Lucknow, Uttar Pradesh, India

Location

MeSH Terms

Interventions

Mycobacterium w vaccine; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sudhir Rawal, MD

  Rajiv Gandhi Cancer Institute

  PRINCIPAL INVESTIGATOR

• Arup Kumar Mandal, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Devakar Dalela, MD

  Chatrapati Sahuji Mahraj Medical University

  PRINCIPAL INVESTIGATOR

• N K Mohanty, M.D.

  Safdarjang Hospital

  PRINCIPAL INVESTIGATOR

• Jayesh Dhabalia, MD

  SEth G S Medical College & KEM Hospital

  PRINCIPAL INVESTIGATOR

• Arun Chawla, MD

  Kasturba Medical College

  PRINCIPAL INVESTIGATOR

• Sujata Patwardhan, MD

  LTMMC & LTMGH

  PRINCIPAL INVESTIGATOR

• P G Jayaprakash, MD

  RCC, Trivandrum

  PRINCIPAL INVESTIGATOR

• Amil Lal Bhat, MD

  S.P. Medical College & A.G. Hospitals

  PRINCIPAL INVESTIGATOR

• Raju T Chacko, MD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

• Sushil Bhatia, MD

  Choithram Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Kim Mammen, MD

  Christian Medical College, Ludhiana

  PRINCIPAL INVESTIGATOR

• K C Lakshmaiah, MD

  Kidwai Memorial Istitute of Oncology

  PRINCIPAL INVESTIGATOR

• Rajeev Gupta, MD

  Patel Hospital Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2007
• First Posted: September 5, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

IN (14)