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A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
Conditions
Advanced Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nanoxel (Paclitaxel Nanoparticle formulation )
Type: Drug
Overall Status
Recruiting
Summary
This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
- Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
- Patients must be of 18-65 years of age (inclusive of both)
- Patients with ECOG performance status between 0 - 2
- Patients with at least one measurable lesion as per RECIST
Exclusion Criteria:
- Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.
- Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
- Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).
- Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
- Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
- Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
- Patients must be of 18-65 years of age (inclusive of both)
- Patients with ECOG performance status between 0 - 2
- Patients with at least one measurable lesion as per RECIST
Exclusion Criteria:
- Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.
- Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
- Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).
- Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
Locations
Nizam'S Institute of Medical Sciences
Hyderabaad, Andhra Pradesh, India
Kidwai Memorial Institute of Oncology
Status: Recruiting
Contact: D. Raghunadharao, DM - +91.40.23372947 - draghu_hyd@dataone.in
Bangalore, Karnataka, India
SEAROC Cancer Center, S K Soni Hospital
Status: Recruiting
Contact: Govind Babu - +91.80.26579503 - kgbtrials@yahoo.co.in
Jaipur, Rajasthan, India
Status: Recruiting
Contact: Anish Maru, DM - +91-0141-2232409-11 - anishmaru@yahoo.com
Start Date
March 2009
Completion Date
April 2010
Sponsors
Fresenius Kabi Oncology Ltd.
Source
Fresenius Kabi Oncology Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page