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

Advanced Breast Cancer Clinical Trial

Official title:

A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00915369
• Other study ID #: DO/NDR/02/2008/01
• Status: Recruiting
• Phase: Phase 1
• First received: June 3, 2009
• Last updated: February 5, 2010
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2010
• Source: Fresenius Kabi Oncology Ltd.
• Contact: Shivakant Mishra, PhD
• Phone: +91.120.4378604
• Email: shivakant.mishra[@]fresenius-kabi.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Nanoxel (Paclitaxel Nanoparticle formulation )
Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.

Locations

Country	Name	City	State
India	Kidwai Memorial Institute of Oncology	Bangalore	Karnataka
India	Nizam'S Institute of Medical Sciences	Hyderabaad	Andhra Pradesh
India	SEAROC Cancer Center, S K Soni Hospital	Jaipur	Rajasthan

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi Oncology Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity		Throughout the study	Yes
Secondary	evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.		Throughout the study	Yes