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A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Quest PharmaTech Inc.
Information provided by (Responsible Party):
Quest PharmaTech Inc.
ClinicalTrials.gov Identifier:
NCT01616303
First received: May 30, 2012
Last updated: April 5, 2017
Last verified: April 2017
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Purpose
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. This study is to confirm previous results that showed oregovomab was able to help the body to produce an immune response to CA125 (a target that has been identified on ovarian cancer cells) in patients with stage III-IV ovarian cancer when they were receiving chemotherapy for their disease. The primary aim of the study is to see how well these patients with advanced ovarian cancer make an immune response to CA125 by using a specific test (enzyme-linked immunospot (ELISPOT) assay) of the patient's blood. The study will also look at the side effects of the oregovomab, other immune response parameters, how well the patients respond to the treatment of their disease (how long it takes to show that their disease has progressed and how long these patients survive overall).
| Condition | Intervention | Phase |
|---|---|---|
| Ovarian Neoplasms | Drug: Carboplatin & paclitaxel Biological: Carboplatin & paclitaxel & oregovomab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
U.S. FDA Resources
Further study details as provided by Quest PharmaTech Inc.:
Primary Outcome Measures:
- Change in CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approxmately 25 weeks after Cycle 1) ]
Secondary Outcome Measures:
- Time to clinical relapse [ Time Frame: Study termination (approxmiately 25 weeks after Cycle 1) ]The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.
- Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity) [ Time Frame: HAMA: screening, Cycle 3 (approx. 6 weeks after Cycle 1), Cycle 5 (approx. 12 weeks after Cycle 1), Cycle 5 plus 12 weeks (approx. 24 weeks after Cycle 1) DTH: screening and termination (approx. 25 weeks after Cycle 1) ]Laboratory test for human anti-mouse antibody (HAMA) present in patients' sera. DTH (delayed type hypersensitivity) is an on-site test conducted by the investigator by injecting a small amount of the Oregovomab product and three other antigens (mumps, tetanus, and Candida) into the skin of the patient and observing the effects.
- Clinical response [ Time Frame: Up to three years after enrollment in the study ]Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]
- Survival [ Time Frame: Up to three years after enrollment in the study ]The observed length of life from entry into the study to death or the date of last contact
- Change in vital signs from baseline to end of study [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), Cycle 3 (approximately 6 weeks after Cycle 1), Cycle 5 (approximately 12 weeks after Cycle 1) and Cycle 5 plus 12 weeks (approxmately 24 weeks after Cycle 1) ]The following vital signs will be obtained: heart rate, respiratory rate, blood pressure, temperature
- Change in clinical laboratory results from baseline to end of chemotherapy [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), Cycle 3 (approximately 6 weeks after Cycle 1), Cycle 5 (approximately 12 weeks after Cycle 1), Cycle 5 plus 12 weeks (approxmately 24 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1) ]The following clinical laboratory results will be obtained: hematology (White Blood Cells [total count and differential], hemoglobin, hematocrit, Red Blood Cells), biochemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin [total], lactate dehydrogenase, protein, creatinine, urea, bicarbonate, chloride, potassium, sodium, calcium, phosphate, glucose, uric acid) and urinalysis (dipstick, pH, specific gravity, bilirubin, blood, protein, glucose, ketones, urobilinogen, microscopic evaluation)
| Enrollment: | 97 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2018 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Carboplatin & paclitaxel
first-line chemotherapy for ovarian cancer
|
Drug: Carboplatin & paclitaxel
Carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])
Other Names:
|
|
Experimental: Carboplatin & paclitaxel & oregovomab
first-line chemotherapy for ovarian cancer plus oregovomab
|
Biological: Carboplatin & paclitaxel & oregovomab
Carboplatin (AUC 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days]) plus oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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=0)
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616303
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616303
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Indiana | |
| Northern Indiana Cancer Research Consortium | |
| South Bend, Indiana, United States, 46601 | |
Sponsors and Collaborators
Quest PharmaTech Inc.
Investigators
| Study Director: | Thomas Woo, M.Sc. | Quest PharmaTech Inc. |
| Study Chair: | Christopher Nicodemus, MD FACP | AIT Strategies |
More Information
Additional Information:
Publications:
| Responsible Party: | Quest PharmaTech Inc. |
| ClinicalTrials.gov Identifier: | NCT01616303 History of Changes |
| Other Study ID Numbers: |
QPT-ORE-002 2010-024305-13 ( EudraCT Number ) |
| Study First Received: | May 30, 2012 |
| Last Updated: | April 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Quest PharmaTech Inc.:
|
ovarian cancer neoplasm adenocarcinoma CA125 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Paclitaxel |
Albumin-Bound Paclitaxel Carboplatin Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 23, 2017