| 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) continued from no. 13 * Poorly Controlled Hypertension is defined as: Blood pressure that in the opinion of the investigator is consistently elevated beyond what the investigator believes to be clinically acceptable for an individual patient, given that patient's medical and psychological status. Failure of this condition to respons to appropriate medical treatment would be exclusionary.
15) The patient has any history of brain metastases or leptomeningeal disease. Screening for CNS involvement for testing asymptomatic patients is not required.
16) The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
17) The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [beta-HCG] test) or lactating. |