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Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Closed
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18 and over
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Pharmaceutical / Industry
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SON-8184-1074 NCT00096668
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Trial Description
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 efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel. Further Study Information 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 Criteria Inclusion Criteria: - Female patient with histologic diagnosis of breast carcinoma
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Sonus Pharmaceuticals Michael Stewart, MD | | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00096668 Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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