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Trial NCT00070031

Resource URI: http://static.linkedct.org/resource/trials/NCT00070031
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linkedct:brief_title Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:condition <http://static.linkedct.org/resource/condition/1883>
linkedct:criteria DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary adenocarcinoma of the breast - Locally advanced or metastatic disease - Not amenable to surgery or radiotherapy with curative intent - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR 10 mm by CT scan - Not previously irradiated - Meets 1 of the following criteria: - Previously treated with anthracycline and concurrent or sequential taxane therapy - Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following: - Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease - Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy - Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease - No known brain metastases or carcinomatous meningitis* NOTE: *Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases - No spinal cord compression - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present) - Albumin at least 3.0 g/dL Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - LVEF at least 50% or ULN by echocardiogram or MUGA - None of the following within the past 6 months: - Myocardial infarction - Severe or unstable angina - Symptomatic congestive heart failure - Cerebrovascular accident or transient ischemic attack - Deep vein thrombosis or other significant thromboembolic event - No ongoing cardiac dysrhythmias grade 2 or greater - No atrial fibrillation of any grade Pulmonary - No pulmonary embolism within the past 6 months Gastrointestinal - No active inflammatory bowel disease - No partial or complete bowel obstruction - No chronic diarrhea Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - No active infection - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or confound study results PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biological response modifiers - No concurrent immunotherapy - No concurrent sargramostim (GM-CSF) - No other concurrent granulocyte colony-stimulating factors Chemotherapy - See Disease Characteristics - Prior adjuvant chemotherapy allowed - No prior topoisomerase I inhibitors - No more than 2 prior chemotherapy regimens for advanced disease - No prior high-dose chemotherapy that required hematopoietic stem cell rescue - No other concurrent chemotherapy Endocrine therapy - Prior adjuvant hormonal therapy or hormonal therapy for advanced/metastatic disease allowed provided that therapy is discontinued before study entry - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - No prior radiotherapy to more than 25% of the bone marrow - No concurrent radiotherapy during and for 5 days after study treatment - Palliative radiotherapy allowed provided no more than 20% of the bone marrow is involved Surgery - No coronary/peripheral artery bypass graft within the past 6 months Other - Recovered from prior therapy (except alopecia or neurotoxicity) - At least 4 weeks since any other prior therapy - More than 4 weeks since prior investigational agents - No concurrent enrollment on another clinical trial - No other concurrent approved or investigational anticancer treatment
linkedct:description OBJECTIVES: Primary - Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer. Secondary - Determine the time to tumor response and duration of response in patients treated with this drug. - Determine the overall survival of patients treated with this drug. - Determine the clinical benefit of this drug in these patients. - Determine the safety and tolerability of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive edotecarin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression. PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 3, 2003
linkedct:id NCT00070031
rdfs:label Trial NCT00070031
linkedct:lastchanged_date December 13, 2009
linkedct:lead_sponsor_agency Memorial Sloan-Kettering Cancer Center
linkedct:location <http://static.linkedct.org/resource/location/153340>
linkedct:nct_id NCT00070031
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
linkedct:org_study_id CDR0000329917
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10274>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/2671>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00070031>
linkedct:phase Phase 2
linkedct:primary_completion_date April 2006
linkedct:secondary_id MSKCC-03056
linkedct:secondary_id PHARMACIA-EDOABC-4439-001
linkedct:source National Cancer Institute (NCI)
linkedct:start_date June 2003
linkedct:study_design Treatment, Open Label
linkedct:study_type Interventional
linkedct:summary RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
rdf:type linkedct:trials
linkedct:verification_date December 2009