Status:
COMPLETED
Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer
Lead Sponsor:
Achieve Life Sciences
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 e...
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 ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00096668
Start Date
October 1 2004
End Date
September 1 2007
Last Update
June 4 2009
Active Locations (7)
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1
Arkhangelsk Regional Oncology Center
Arkhangelsk, Russia, 163045
2
Moscow Oncology Clinical Hospital #62
Krasnogorskiy Region, Russia, 143423
3
Blokhin Russian Oncology Center
Moscow, Russia, 115478
4
Semashko Central Clinical Hospital of the Ministry of Transport
Moscow, Russia, 129128