Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Stopped early · Phase 2

Conditions studied: Fallopian Tube Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Malignant Ovarian Brenner Tumor, Ovarian Adenocarcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

In brief

This randomized phase II trial studies the side effects of paclitaxel and bevacizumab with or without emactuzumab and how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back after treatment with platinum chemotherapy. Monoclonal antibodies, such as emactuzumab, block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumors need to grow. Giving emactuzumab with paclitaxel and bevacizumab may work better in treating ovarian, fallopian tube, or primary peritoneal cancer.

Key facts

Study ID

NCT02923739

Run by

M.D. Anderson Cancer Center

People needed

9

Starts

2017-05-05

Expected to finish

2022-09-27

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements (inclusive of 2 biopsies, one at baseline and if they qualify, one pre-randomization for part 2B)
• Women 18 years of age or older
• Histologically confirmed and documented disease to include: adenocarcinoma NOS (not otherwise specified), clear cell adenocarcinoma, endometrioid adenocarcinoma, malignant Brenner's tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma, and undifferentiated carcinoma
• Patients must have platinum-resistant disease, (defined as progression within < 6 months from completion of a minimum of 4 platinum therapy cycles (+ 7 days); the date should be calculated from the last administered dose of platinum therapy)
• Patients must have disease that is measurable according to RECIST 1.1 or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment; part 1: patients must have one or more measurable target lesion; part 2: patients must have two or more measurable target lesions; measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each 'target' lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Newly obtained core or excisional biopsy of a tumor lesion for part 2A and if they qualify, one pre-randomization biopsy for part 2B
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >=9 g/dL or >= 5.6 mmol/L
• Creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional upper limit of normal (ULN)
• Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGOT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases
• International normalized ratio (INR)/prothrombin time (PT) =< 1.5 X ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants)
• PTT =< 1.5 X ULN (unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)
• Life expectancy of >= 12 weeks

You may not qualify if…

• Patients who have disease progression prior to completion of intended frontline therapy, including patients demonstrating disease progression after interval cytoreduction
• Non-epithelial, including malignant mixed Mullerian tumors
• Ovarian tumors with low malignant potential (i.e. borderline tumors)
• For part 2 patients only: History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast, or early stage endometrial cancer (stage IA/B, grade 1 or 2, endometrioid histology)
• Previous treatment with > 2 anticancer regimens for ovarian cancer
• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exceptions: hormone-replacement therapy or oral contraceptives; tyrosine kinase inhibitors (TKIs) that have been discontinued > 7 days prior to cycle 1, day 1; screening scans must be obtained after discontinuation of prior TKIs
• Any prior radiotherapy to the pelvis or abdomen
• Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study; minor surgical procedures including placement of a vascular access device, within 2 days of the first study treatment
• Previous exposure to murine CA-125 antibody (only applicable to those patients with non-measurable disease by RECIST)
• Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day)
• Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study
• Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to cycle 1, day 1; patients who have received acute and/or lowrolment, or anticipation of need for major surgical, a one-time dose of dexamethasone for nausea or chronic use of =< 10 mg/day of prednisone or dose-equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the medical monitor; the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed; prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
• Received therapeutic oral or IV antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
• Patients with urine dipstick for proteinuria > 2+; patients with >= 2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate =< 1 g of protein in the 24-hour urine; alternatively, proteinuria testing can be performed according to local standards
• Patients with known auto-immune disease
• Patients with known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
• Patient has received an organ transplant
• Patient has a history of hematological malignancy within the last 5 years prior to study entry; prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Patient has a history of hematological malignancy within the last 5 years prior to study entry
• History of or active autoimmune disease including, but not limited to, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, and vasculitis or glomerulonephritis; patients with autoimmune thyroid disease on a stable thyroid replacement regimen; controlled vitiligo, eczema, psoriasis, or seborrheic dermatitis with only dermatologic manifestations; or controlled type I diabetes on a stable insulin regimen may be eligible for the study with approval by the medical monitor
• History or evidence upon physical/neurological examination of central nervous system (CNS) disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures)
• Symptomatic CNS metastasis
• Pre-existing peripheral neuropathy >= Common Terminology Criteria (CTC) grade 2 for those patients who received prior paclitaxel
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to screening
• Increased corrected QT (QTc) interval (QTc > 470 ms), patients with baseline resting bradycardia < 45 beats per minute (bpm), or baseline resting tachycardia > 100 bpm

Where it is running

• MD Anderson Cancer Center at Cooper-Voorhees — Voorhees Township, New Jersey, United States
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• The Woman's Hospital of Texas — Houston, Texas, United States
• MD Anderson Regional Care Center-Katy — Houston, Texas, United States
• MD Anderson Regional Care Center-Bay Area — Nassau Bay, Texas, United States
• MD Anderson Regional Care Center-Sugar Land — Sugar Land, Texas, United States
• MD Anderson Regional Care Center-The Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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