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A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer Clinical research trials and A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer. A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer  A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer
A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer
For Condition: Ovarian Cancer
Status: Recruiting
Sponsor(s): Genentech ,
Synopsis: The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Signed informed consent - Willingness to undergo tumor biopsy and disease that is amenable to biopsy (Cohort 1 only) - Age >= 18 years old - Advanced, histologically documented carcinoma of the ovary - Measurable disease with at least one lesion that can be accurately measured per RECIST in at least one dimension (longest dimension recorded). Each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT, and MRI, or >= 10 mm when measured by spiral CT; OR clinically or radiologically detectable disease (e.g., ascites, peritoneal deposits, mesenteric thickening or lesions that do not fulfill RECIST for measurable disease). In addition, the subject must have two consecutive pre-treatment CA-125 levels that are both greater than 2x the institutional upper limit of normal (ULN) and >= 40 IU/mL, taken at least 1 week and not more than 3 months apart. The second of the two measurements of CA-125 level should be drawn within 28 days following the screening biopsy. The later value must be within 2 weeks of starting pertuzumab treatment. - One or more prior platinum-based chemotherapeutic regimens for the management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment. Subjects with only one prior platinum-based treatment regimen must have an initial treatment-free interval of < 12 months. Subjects with an initial treatment-free interval of > 12 months are eligible if they have progressed following re-treatment with second-line chemotherapy (e.g., either platinum- or taxane-based, topotecan, or liposomal doxorubicin). There is no upper limit on the number of prior regimens. - Life expectancy of >= 12 weeks - ECOG performance status 0 or 1 - Use of an effective means of contraception (for women of childbearing potential) - Granulocyte count >= 1500/microliter, platelet count of >= 75,000/microliter and hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoietin [Aranesp] is permitted) - Serum bilirubin <= 1.5 x the ULN and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects with liver metastasis) - Serum creatinine <= 1.5 x ULN - International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 ULN (except for subjects receiving warfarin) Exclusion Criteria: - Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1 (the day on which the first rhuMAb 2C4 infusion is administered) - Prior treatment with HER pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, TAK165 - History or clinical evidence of central nervous system or brain metastasis - Ejection fraction, determined by ECHO, <50% - Uncontrolled hypercalcemia (> 11.5 mg/dL) - Prior exposure of > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2 mitoxantrone, or > 90 mg/m2 idarubicin - History of other malignancies within 5 years of Day 1 except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or squamous cell skin cancer - History of serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure > 100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible) - Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Known human immunodeficiency virus infection - Pregnancy or lactation - Major surgery or significant traumatic injury within 3 weeks prior to Day 1 with the exception of tumor biopsy for the purposes of the study - Inability to comply with study and follow-up procedures - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
Total Enrollment: 60
Location and Contact Information:
Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Russell Schilder 888-369-2427
OSU College of Medicine, James Cancer Hospital & Solove Research Institute *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Jodi Catanzarite 614-293-3873
Arizona Cancer Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Debbie Pilkington 320-626-3694
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Lisa Mazzetti 617-724-4102
Memorial Sloan Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Aghajanian 646-497-9055
Arizona Cancer Center *Recruiting*
Scottsdale, Arizona, 85012
United States
Recruiting Michael Gordon 480-657-1350
Indiana University, Division of Oncology/Cancer Pavilion *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Nancy Menning 317-274-1658
University of California, Los Angeles *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Mark Pegram 888-798-0719
Sarah Cannon Cancer Center *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Danielle Carpenter 615-986-4316
University of Chicago Medical Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Bernie Libao 773-834-1758
Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Erin Vincent-Brunick 617-632-2580
Additional Information:
Study ID Numbers: TOC2689g;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058552
Other Ovarian Cancer Studies:
1. SU5416 and Carboplatin to Treat Ovarian Cancer
2. Clinical Trial for Ovarian Cancer (OvaRex®)
3. Phase 2 study of ET-743 in subjects with advanced ovarian cancer
4. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
5. A study of the safety and effects of EMD 72000 in subjects with recurrent ovarian cancer
Related Studies:
Other Ovarian Cancer Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
A Study to Evaluate the Safety and Effect of Pertuzumab on Cancerous Lesions in Women with Advanced, Refractory or Recurrent Ovarian Cancer
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