Overview

A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer

Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fresenius Kabi Oncology Ltd.
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
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).