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Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Clinical research trials and Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer. Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer  Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
For Condition: Fallopian Tube Cancer,peritoneal cavity cancer,ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with cetuximab in treating patients who have newly diagnosed stage III or stage IV ovarian epithelial, fallopian tube, or primaryperitoneal cavity cancer.
Details: OBJECTIVES: Primary - Determine the progression-free survival of patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with cetuximab, paclitaxel, and carboplatin. Secondary - Determine the clinical response rate in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response may receive an additional 6 months of cetuximab maintenance therapy. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 39 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 confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer - Stage III or IV disease, including the following epithelial cellular types: - Serous adenocarcinoma - Endometrioid adenocarcinoma - Mucinous adenocarcinoma - Undifferentiated carcinoma - Clear cell adenocarcinoma - Mixed epithelial adenocarcinoma - Transitional cell carcinoma - Malignant Brenner tumor - Adenocarcinoma not otherwise specified - Underwent initial surgery for tumor within the past 12 weeks - Optimal (no greater than 1 cm) or suboptimal residual disease after surgery - Epidermal growth factor receptor expression positive by immunohistochemistry (e.g., 1+) - No ovarian epithelial tumor of low malignant potential (borderline carcinoma) - Prior low malignant potential tumor allowed provided it was surgically resected and invasive adenocarcinoma subsequently develops PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least lower limit of normal Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - No acute hepatitis Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No significant history of cardiac disease - No unstable angina - No congestive heart failure - No uncontrolled hypertension - No abnormal baseline ECG Other - Not pregnant or nursing - Surgically sterile by hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - No known allergy to murine proteins or Cremophor EL - No greater than grade 1 sensory neuropathy - No active or uncontrolled infection - No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast or head and neck cancer - No other malignancies whose prior treatment contraindicates study therapy - No prisoners - No patients compulsorily detained for treatment of a psychiatric illness or physical illness (e.g., infectious disease) PRIOR CONCURRENT THERAPY: Biologic therapy - No prior cetuximab - No prior chimerized or murine monoclonal antibody therapies Chemotherapy - Prior adjuvant chemotherapy for localized breast cancer allowed provided treatment was completed more than 3 years before study entry and patient remains free of recurrent or metastatic disease - No prior chemotherapy for any ovarian tumor - No prior chemotherapy for any other abdominal or pelvic tumor - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided treatment was completed more than 3 years before study entry and patient remains free of recurrent or metastatic disease - No prior radiotherapy to any portion of the abdominal cavity or pelvis - No concurrent radiotherapy Surgery - See Disease Characteristics Other - No prior therapy targeting the epidermal growth factor receptor pathway - No other concurrent investigational anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DennisChi, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Aghajanian 212-639-2252
Additional Information:
Study ID Numbers: CDR0000329918; MSKCC-03025,BMS-CA225-009
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070044
Other Ovarian Epithelial Cancer Studies:
1. Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
2. Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
3. Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
4. Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- based Chemotherapy
5. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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