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Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Basic Trial Information
Summary The purpose of this study is to determine if IMC-1121B given as monotherapy is effective in the treatment of Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma. Further Study Information Current chemotherapies used to treat ovarian cancer patients include doxorubicin, topotecan, and paclitaxel, to mention a few. Doxorubicin was studied in ovarian cancer patients that were refractory to paclitaxel and platinum-based chemotherapy agents. Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. VEGF is an important regulator of angiogenesis and is likely an important therapeutic target in persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. VEGF is overexpressed in ovarian tissue and may be the most important single tumor angiogenic factor. Phase 1 studies currently nearing completion with IMC-1121B have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in ovarian cancer patients. Therefore, ImClone Systems plans to conduct a Phase 2 trial to assess the safety and efficacy of IMC-1121B in patients with platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Eligibility Criteria Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study: 1. The patient has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via a pathology report. 2. The patient has at least one unidimensional-measurable target lesion (≥ 2 cm with conventional techniques, or ≥ 1 cm by spiral computed tomography [CT] or magnetic resonance imaging [MRI]), as defined by Response Evaluation Criteria in Solid Tumors (RECIST).[55] Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. 3. The patient has recovered to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to Grade ≤ 2). Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. Continuation of hormone replacement therapy is permitted. 4. The patient has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of < 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy. 5. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry. 6. The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥ 1200 cells/uL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000 cells/uL). 7. The patient has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal [ULN]; aspartate transaminase [AST] and/or alanine transaminase [ALT] ≤ 3.0 times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver metastases). 8. The patient has adequate renal function (serum creatinine ≤ 1.5 x ULN or creatinine clearance [measured or calculated] ≥ 60 mL/min). 9. The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study. 10. The patient has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices). 11. For patients who have received anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within normal institutional range by a pretreatment echocardiogram or multigated acquisition (MUGA) scan. 12. If sexually active, the patient is post-menopausal, surgically sterile, or using effective contraception in the opinion of the investigator. 13. The patient is ≥ 18 years of age. 14. The patient has a life expectancy of ≥ 3 months. 15. The patient is able to provide informed written consent and is amenable to compliance with protocol schedules and testing. Exclusion Criteria: 1. The patient has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible provided that she has been disease-free for > 3 years. 2. The patient has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (Patients may have received a noncytotoxic regimen as primary treatment.) 3. The patient has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication. 4. The patients has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. (Prior radiation for localized cancer [eg, of the breast, head and neck, or skin] is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the patient remains free of recurrent or metastatic disease.) 5. The patient has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3 years prior to the first dose of study medication. Prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed >3 years prior to the first dose of study medication, and that the patient remains free of recurrent or metastatic disease. 6. The patient has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication. 7. The patient has a suspected impending bowel obstruction, based on clinical or radiographic criteria. 8. The patient has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication. 9. The patient has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication. 10. The patient has received previous treatment with IMC-1121B. 11. The patient has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication. 12. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders. 13. The patient has an ongoing or active infection requiring systemic antibiotics,symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6 months, Grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator. 14. The patient has any history of brain metastases or leptomeningeal disease. Screening for CNS involvement for testing asymptomatic patients is not required. 15. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness. 16. The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [β-HCG] test) or lactating. Trial Lead Organizations/Sponsors ImClone Systems, Incorporated
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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