A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma
2 other identifiers
interventional
97
1 country
2
Brief Summary
This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2018
CompletedSeptember 14, 2020
September 1, 2020
3 years
May 30, 2012
September 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy
Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy
At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1)
Secondary Outcomes (4)
Time to clinical relapse
Up to three years after treatment in the study
Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity)
Up to three years after treatment in the study
Clinical response
Up to three years after treatment in the study
Overall Survival
Up to three years after treatment in the study
Study Arms (2)
carboplatin & paclitaxel
ACTIVE COMPARATORfirst-line chemotherapy for ovarian cancer
carboplatin & paclitaxel & oregovomab
EXPERIMENTALfirst-line chemotherapy for ovarian cancer plus oregovomab
Interventions
carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks \[21 days\])
Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks \[21 days\])
oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
Eligibility Criteria
You may qualify if:
- have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease.
- have preoperative CA125 levels \> 50 U/mL
- have optimal cytoreduction (RT\<1)
- be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery
- be available to complete the protocol for the duration of the study
- have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/µL; hemoglobin greater than or equal to 8.0 g/dL
- have adequate Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
- have adequate Hepatic function: bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
- able to sign informed consent and provide authorization permitting release of personal health information
- have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
You may not qualify if:
- have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)
- have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or cannot tolerate cyclophosphamide
- are being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
- have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia
- have an acquired, hereditary, or congenital immunodeficiency
- have uncontrolled diseases other than cancer
- have contraindications to the use of pressor agents
- have undergone more than one surgical debulking
- have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin \<3.5 g/dL
- have severe renal insufficiency with serum creatinine \>1.6 mg/dL
- have concomitant diseases or treatments that may confound the results of the study, which may preclude the completion of the protocol or may mask adverse reactions
- are to be tested with other medications during treatment
- are unable to read or understand or unable to sign the necessary written consent before starting treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Related Publications (2)
Brewer M, Angioli R, Scambia G, Lorusso D, Terranova C, Panici PB, Raspagliesi F, Scollo P, Plotti F, Ferrandina G, Salutari V, Ricci C, Braly P, Holloway R, Method M, Madiyalakan M, Bayever E, Nicodemus C. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study. Gynecol Oncol. 2020 Mar;156(3):523-529. doi: 10.1016/j.ygyno.2019.12.024. Epub 2020 Jan 6.
PMID: 31916979RESULTBattaglia A, Buzzonetti A, Fossati M, Scambia G, Fattorossi A, Madiyalakan MR, Mahnke YD, Nicodemus C. Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer patients. Cancer Immunol Immunother. 2020 Mar;69(3):383-397. doi: 10.1007/s00262-019-02456-z. Epub 2020 Jan 3.
PMID: 31897661RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Woo, M.Sc.
Quest PharmaTech Inc.
- STUDY CHAIR
Christopher Nicodemus, MD FACP
AIT Strategies
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 11, 2012
Study Start
June 15, 2012
Primary Completion
June 15, 2015
Study Completion
October 12, 2018
Last Updated
September 14, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share