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Trial Title:
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
NCT ID:
NCT00915369
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nanoxel (Paclitaxel Nanoparticle formulation )
Description:
Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375
mg/m2. Each patient will recieve upto 6 cycles.
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:
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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nizam'S Institute of Medical Sciences
Address:
City:
Hyderabaad
Country:
India
Status:
Recruiting
Contact:
Last name:
D. Raghunadharao, DM
Phone:
+91.40.23372947
Email:
draghu_hyd@dataone.in
Investigator:
Last name:
D Raghunadharao, DM
Email:
Principal Investigator
Facility:
Name:
Kidwai Memorial Institute of Oncology
Address:
City:
Bangalore
Country:
India
Status:
Recruiting
Contact:
Last name:
Govind Babu
Phone:
+91.80.26579503
Email:
kgbtrials@yahoo.co.in
Investigator:
Last name:
Govind Babu, DM
Email:
Principal Investigator
Facility:
Name:
SEAROC Cancer Center, S K Soni Hospital
Address:
City:
Jaipur
Country:
India
Status:
Recruiting
Contact:
Last name:
Anish Maru, DM
Phone:
+91-0141-2232409-11
Phone ext:
106
Email:
anishmaru@yahoo.com
Investigator:
Last name:
Anish Maru, DM
Email:
Principal Investigator
Start date:
March 2009
Completion date:
April 2010
Lead sponsor:
Agency:
Fresenius Kabi Oncology Ltd.
Agency class:
Industry
Source:
Fresenius Kabi Oncology Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00915369
