A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

Genetic and Rare Diseases Information Center resources: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to clinical relapse [ Time Frame: Study termination (approxmiately 25 weeks after Cycle 1) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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)


Estimated Enrollment:	80
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: Abraxane Paclitaxel Carboplatin
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: Abraxane Palictaxel Carboplatin Oregovomab

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:

Abraxane
Paclitaxel
Carboplatin

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:

Abraxane
Palictaxel
Carboplatin
Oregovomab

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders 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

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:

Sponsor website This link exits the ClinicalTrials.gov site

Publications:

Braly P, Nicodemus CF, Chu C, Collins Y, Edwards R, Gordon A, McGuire W, Schoonmaker C, Whiteside T, Smith LM, Method M. The Immune adjuvant properties of front-line carboplatin-paclitaxel: a randomized phase 2 study of alternative schedules of intravenous oregovomab chemoimmunotherapy in advanced ovarian cancer. J Immunother. 2009 Jan;32(1):54-65. doi: 10.1097/CJI.0b013e31818b3dad.


Responsible Party:	Quest PharmaTech Inc.
ClinicalTrials.gov Identifier:	NCT01616303 History of Changes
Other Study ID Numbers:	QPT-ORE-002 2010-024305-13
Study First Received:	May 30, 2012
Last Updated:	March 29, 2016
Health Authority:	United States: Food and Drug Administration Italy: Ministry of Health
Individual Participant Data
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 September 28, 2016