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Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy Clinical research trials and Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy clinical trial. Participants oftentimes recieve the finest healthcare available for their Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy  Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
For Condition: recurrent breast cancer,stage 4 breast cancer,stage 3A breast cancer,stage 3B breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of edotecarin in treating women who have locally advanced or metastatic breast cancer that has not responded to previous treatment with anthracycline or taxane chemotherapy.
Details: OBJECTIVES: Primary - Determine the antitumor activity of edotecarin, in terms of overall confirmed objective response rate (complete or partial), in women with anthracycline- and taxane-resistant 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 time to progression and time to treatment failure in patients treated with this drug. - Determine the overall survival of patients treated with this drug. - Determine the clinical benefit of this drug, in terms of pain intensity, analgesic consumption, and performance status, 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 21 days. Patients with stable disease are followed radiographically for response every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - Previously treated with anthracycline and concurrent or sequential taxane therapy - Resistant 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 - 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 - No myocardial infarction within the past year - No severe/unstable angina within the past year - No symptomatic congestive heart failure within the past year - No cerebrovascular accident or transient ischemic attack within the past year - No deep vein thrombosis or other significant thromboembolic event within the past year - No ongoing cardiac dysrhythmias grade 2 or greater - No atrial fibrillation of any grade Pulmonary - No pulmonary embolism within the past year 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 - HIV negative - 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) 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 2 weeks 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 year Other - Recovered from prior therapy (except alopecia or neurotoxicity) - At least 4 weeks since any 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CliffordHudis, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Andrew Seidman 212-639-5875
Additional Information:
Study ID Numbers: CDR0000329917; PHARMACIA-EDOABC-4439-001,MSKCC-03056
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070031
Other Stage 3a Breast Cancer Studies:
1. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
2. Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
3. Biological Therapy in Treating Patients With Advanced Cancer
4. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
5. Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
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