Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer

A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients With Metastatic Breast Cancer

This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: TOCOSOL(R) Paclitaxel

Detailed Description

This is an open label, non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level, 120mg/m2, known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses. This study is a fixed sample size design with no planned early stopping decision. The goals of the study include the determination of the safety of TOCOSOL Paclitaxel, and the objective response rate, defined by RECIST criteria as complete responses plus partial responses.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Regional Oncology Center
  • Krasnogorskiy Region, Russian Federation, 143423
    • Moscow Oncology Clinical Hospital #62
  • Moscow, Russian Federation, 115478
    • Blokhin Russian Oncology Center
  • Moscow, Russian Federation, 129128
    • Semashko Central Clinical Hospital of the Ministry of Transport
  • St Petersburg, Russian Federation, 197758
    • Petrov Research Institute of Oncology
  • St Petersburg, Russian Federation, 197022
    • St Petersburg Oncology Center
  • Voronezh, Russian Federation, 3394000
    • Voronezh Regional Clinical Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patient with histologic diagnosis of breast carcinoma
• Stage IV (M1) disease
• No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer
• Adult (18 years of age or older) patients
• Adequate hematologic function (ANC >=1500 cells/mm3 and platelets >100,000/mm3
• Serum creatinine <=2.0 mg/dL
• Total bilirubin <=1.5 mg/dL
• AST/SGOT and ALT/SGPT <=3 times the upper limit of institutional normal values
• PT and PTT within institutional normal range
• ECOG performance status of 0-2
• At least one unidimensionally measurable lesion as defined by RECIST criteria assessable by radiographic evaluation
• A signed IRB/Ethics Committee approved Informed Consent
• Life expectancy of at least 12 weeks
• Fully recovered from any previous surgery
• A negative pregnancy test prior to study entry if premenopausal
• Agree not to take Vitamin E supplementation while receiving study medication

Exclusion Criteria:

• Any prior taxane-containing chemotherapy including Taxol or Taxotere
• Patients who are pregnant or lactating
• Peripheral neuropathy NCI-CTC grade 2 or greater
• Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug
• Treatment with an investigational agent within 4 weeks of first dose of study drug
• Patients with a history of carcinomas of primary sites which can not be distinguished histologically from metastatic breast carcinoma
• Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic breast carcinoma
• Brain metastases
• Active bowel obstruction
• Active, serious infection or other serious medical problems (other than metastatic breast cancer) likely to impair completion of the study protocol
• Concurrent therapy with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 or CYP3A4
• Concurrent therapy with warfarin or other coumarin derivatives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TOCOSOL Paclitaxel; TOCOSOL Paclitaxel administered weekly at 120mg/mm2	Drug: TOCOSOL(R) Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability	After all patients complete treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	After alll patients complete treatment

Collaborators and Investigators

• Sponsor: Achieve Life Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): September 1, 2007
• Study Completion (ACTUAL): September 1, 2007

Study Registration Dates

• First Submitted: November 12, 2004
• First Submitted That Met QC Criteria: November 12, 2004
• First Posted (ESTIMATE): November 15, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2009
• Last Update Submitted That Met QC Criteria: June 2, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Breast cancer; TOCOSOL Paclitaxel
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: SON-8184-1074