A clinical trial to study the effects of Nanoparticle based Paclitaxel drug, which does not contain the solvent cremophor, in advanced breast cancer

Phase 1

Completed

Registration Number: CTRI/2009/091/000219

Lead Sponsor: FreseniusKabi Oncology Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 21

Inclusion Criteria

i. Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
ii.Patients with ER/PR ?ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
iii.Patients must be of 18-65 years of age
iv.Patients with ECOG performance status between 0 ? 2
v.Patients with at least one measurable lesion as per RECIST

Exclusion Criteria

i.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.
ii.Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
iii.Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease.
iv.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To generate the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2)and to determine the maximum tolerated dose (MTD) of Nanoxel ; <br>Evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc (Safety evaluation)Timepoint: Dose Limiting Toxicity (DLT) occuring at the mentioned levels of Nanoxel infusion will define the MTD. <br>Safety evaluation by recording ECG's at various timepoints during and post infusion.

Secondary Outcome Measures