Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: IV infusion (test product)-Oregovomab: Paclitaxel - 175 mg/m2 infused over 3 hours (or as per institutional guidelines) in every 3 weekly cycle.
Carboplatin - AUC 6 IV administered ove
Sponsors
OncoQuest Pharmaceuticals Inc
Raptim Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult females 18 years old or older. 2. Patients with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Eligible histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.). 4. Suitable venous access for the study-required procedures. 5. Serum CA125 levels â�¥ 50 U/mL prior to Cycle 1 of chemotherapy + oregovomab or placebo. 6. Adequate bone marrow function: a. Absolute neutrophil count (ANC) â�¥ 1,500/�¼L. b. Platelets â�¥100,000/�¼L. c. Hemoglobin â�¥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before the first dose of study treatment). 7. Adequate liver function: a. Bilirubin b. LDH, SGOT/AST and SGPT/ALT 8. Adequate renal function: a. Creatinine â�¤ 1.5 times ULN. 9. ECOG Performance Status of 0, 1 or 2. 10. Women of childbearing potential must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment. 11. Sign written informed consent form and authorization permitting release of personal health information.
Exclusion criteria
Exclusion criteria: 1. Patients with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features and low-grade adenocarcinoma (including low grade serous and FIGO grade 1 endometrioid adenocarcinomas of the ovary). 2. Patients must not have received any prior chemotherapy, immunotherapy, targeted or hormonal therapy. 3. Patients who are lactating and breastfeeding or have a positive serum pregnancy test within 14 days prior to the first dose of study treatment. 4. Any serious medical or psychiatric illness that could, in the investigatorââ?¬•s opinion, potentially interfere with the completion of study treatment according to this protocol. 5. Active autoimmune disease such as rheumatoid arthritis, SLE, ulcerative colitis, Crohns Disease, MS, or ankylosing spondylitis, requiring active disease modifying treatment. 6. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin. 7. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone, etc. 8. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.) 9. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia. 10. Clinically significant active infection(s) at the time of screening. Contraindication to the use of pressor agents. 11. Any of the following conditions (on-study testing is not required): a. Known HIV-infected patients unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or b. Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or c. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load. 12. Uncontrolled or life-threatening diseases compromising safety evaluation. 13. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer, ductal carcinoma in-situ (DCIS) of the breast or cervix carcinoma in situ are not excluded if they have undergone complete resection a. Synchronous endometrial cancer, but a prior diagnosis of endometrial cancer within 5 years is not excluded if all of the following conditions are met: Stage IA, superficial myometrial invasion, without lymphovascular invasion, and not poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade III lesions. 14. Contraindication to the use of pressor agents. 15. Undergone prior surgical debulking. 16. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases. 17. Any of the following cardiovascular conditions: a. Acute myocardial infarction within 6 months before the first dose of study treatment. <
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) RateTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) and Disease Control Rate (DCR)Timepoint: End of Cycle 3 and prior to interval debulking surgery | — |
Countries
India
Contacts
Public ContactMustafa Pardiwala
Raptim Research Private Ltd
Outcome results
None listed