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

This study has been completed.
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00096668
First received: November 12, 2004
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: TOCOSOL(R) Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:
  • Tolerability [ Time Frame: After all patients complete treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: After alll patients complete treatment ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: October 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOCOSOL Paclitaxel
TOCOSOL Paclitaxel administered weekly at 120mg/mm2
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096668

Locations
Russian Federation
Arkhangelsk Regional Oncology Center
Arkhangelsk, Russian Federation, 163045
Moscow Oncology Clinical Hospital #62
Krasnogorskiy Region, Russian Federation, 143423
Semashko Central Clinical Hospital of the Ministry of Transport
Moscow, Russian Federation, 129128
Blokhin Russian Oncology Center
Moscow, Russian Federation, 115478
Petrov Research Institute of Oncology
St Petersburg, Russian Federation, 197758
St Petersburg Oncology Center
St Petersburg, Russian Federation, 197022
Voronezh Regional Clinical Oncology Center
Voronezh, Russian Federation, 3394000
Sponsors and Collaborators
OncoGenex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Monica Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00096668     History of Changes
Other Study ID Numbers: SON-8184-1074
Study First Received: November 12, 2004
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoGenex Pharmaceuticals:
Breast cancer
TOCOSOL Paclitaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014