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

This study is currently recruiting participants.

Verified by Fresenius Kabi Oncology Ltd., June 2009

First Received: June 3, 2009 Last Updated: June 5, 2009 History of Changes

Sponsored by:	Fresenius Kabi Oncology Ltd.
Information provided by:	Fresenius Kabi Oncology Ltd.
ClinicalTrials.gov Identifier:	NCT00915369

Purpose

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.

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Nanoxel (Paclitaxel Nanoparticle formulation )	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Fresenius Kabi Oncology Ltd.:

Primary Outcome Measures:

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 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	March 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915369

Contacts

Contact: Shivakant Mishra, PhD	+91.120.4378604	shivakant.mishra@fresenius-kabi.com
Contact: Amit Sharma, MD	+91.120.4378415	amit_delhi.sharma@fresenius-kabi.com

Locations

India, Andhra Pradesh
Nizam's Institute of Medical Sciences	Recruiting
Hyderabaad, Andhra Pradesh, India
Contact: D. Raghunadharao, DM +91.40.23372947 draghu_hyd@dataone.in
Principal Investigator: D Raghunadharao, DM
India, Karnataka
Kidwai Memorial Institute of Oncology	Recruiting
Bangalore, Karnataka, India
Contact: Govind Babu +91.80.26579503 kgbtrials@yahoo.co.in
Principal Investigator: Govind Babu, DM
India, Rajasthan
SEAROC Cancer Center, S K Soni Hospital	Recruiting
Jaipur, Rajasthan, India
Contact: Anish Maru, DM +91-0141-2232409-11 ext 106 anishmaru@yahoo.com
Principal Investigator: Anish Maru, DM

Sponsors and Collaborators

Fresenius Kabi Oncology Ltd.

More Information

No publications provided

Responsible Party:	Fresenius Kabi Oncology Ltd. ( Dr. S. K. Mishra, Vice President - Clinical Research & Medical Services )
Study ID Numbers:	DO/NDR/02/2008/01
Study First Received:	June 3, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00915369 History of Changes
Health Authority:	United States: Food and Drug Administration; India: Drugs Controller General of India

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Tubulin Modulators
Breast Neoplasms

Antimitotic Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on September 03, 2009