|
Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer Clinical research trials and Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer. Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer  Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer
Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer
For Condition: stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies, such as pertuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of pertuzumab in treating women who have advanced refractory or recurrentovarian cancer.
Details: OBJECTIVES: Primary - Determine the overall response rate in patients with advanced refractory or recurrent ovarian cancer with or without detectable HER2 phosphorylation in tumor tissue before therapy when treated with pertuzumab. - Determine the safety and tolerability of this drug in these patients. Secondary - Determine the time to disease progression, duration of response, and survival of patients treated with this drug. - Correlate the pharmacokinetics of this drug with physiologic covariates in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive pertuzumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and at 3-6 months. PROJECTED ACCRUAL: A total of 60 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 ovarian carcinoma - Advanced disease - Refractory or recurrent after prior chemotherapy - Measurable or nonmeasurable disease meeting one of the following criteria: - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR 10 mm by spiral CT scan - Clinical or radiographical evidence of disease (e.g., ascites, peritoneal deposits, mesenteric thickening, or lesions that are not considered measurable disease) in addition to the following: - Disease site amenable to biopsy - Two consecutive pretreatment tests of CA 125 levels measuring greater than 2 times upper limit of normal (ULN) and at least 40 IU/mL drawn at least 1 week and no more than 3 months apart - Received at least 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease - Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment - Prior treatment with only 1 platinum-based regimen is allowed provided one of the following criteria is met: - Initial treatment-free interval of less than 12 months - Disease progression after retreatment with second-line platinum- or taxane-based chemotherapy, topotecan, or doxorubicin HCl liposome - No history or clinical evidence of CNS or brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9 g/dL* NOTE: *Hemoglobin may be supported by transfusion or epoetin alfa or other approved hematopoietic growth factors, including darbepoetin alfa Hepatic - No viral or other hepatitis - No cirrhosis - No ongoing liver disease - INR less than 1.5 - aPTT less than 1.5 times ULN (unless receiving concurrent warfarin) - Bilirubin no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN* - AST and ALT no greater than 2.5 times ULN* NOTE: *No greater than 5 times ULN in the presence of liver metastases Renal - Creatinine no greater than 1.5 times ULN - No uncontrolled hypercalcemia (calcium greater than 11.5 mg/dL) Cardiovascular - Ejection fraction at least 50% by echocardiogram - No uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg on two consecutive occasions) - Controlled hypertension allowed - No unstable angina - No congestive heart failure - No myocardial infarction within the past 6 months - No unstable symptomatic arrhythmia requiring medication - Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 months after study participation - HIV negative - No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No active infection - No other serious systemic disease - No current alcohol abuse - No significant traumatic injury within the past 3 weeks - No other diseases, metabolic dysfunction, physical examination finding, or laboratory finding that would contraindicate use of an investigational drug, confound study results, or render the patient at high risk for treatment complications PRIOR CONCURRENT THERAPY: Biologic therapy - No prior HER2 pathway inhibitors (e.g., trastuzumab [Herceptin®], gefitinib, erlotinib, cetuximab, CI-1033, or Tak-165) - No other concurrent immunotherapy/radioimmunotherapy Chemotherapy - See Disease Characteristics - No prior doxorubicin or doxorubicin HCl liposome dose greater than 360 mg/m^2 - No prior mitoxantrone dose greater than 120 mg/m^2 - No prior idarubicin dose greater than 90 mg/m^2 - No concurrent cytotoxic chemotherapy Endocrine therapy - No concurrent corticosteroids unless on stable dose of less than 20 mg/day of prednisone or equivalent and administered for reasons unrelated to ovarian cancer Radiotherapy - No concurrent radiotherapy - Localized palliative radiotherapy to a single symptomatic bone lesion allowed provided the following conditions are met: - Treatment involves a preexisting site of bony disease with no evidence of disease progression - Total radiation dose does not exceed 40 Gy - Radiation fields do not encompass more than 25% of total bone marrow reserve Surgery - More than 3 weeks since prior major surgery Other - More than 4 weeks since prior experimental anticancer agents - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkPegram, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000334190; UCLA-0303080,GENENTECH-TOC2689g
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070408
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
3. Quality-of-Life Assessment in Patients With Ovarian Cancer
4. National Ovarian Cancer Early Detection Program Screening and Genetic Study
5. Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer
|
|
|
|
|
|
|
|
