Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cabozantinib (XL184) 60 mg once a day continuously, repeated in 4 week cycles until disease progression or adverse effects prohibit further therapy

Cabozantinib

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The Percentage of Patients Who Survive Progression Free for at Least 6 Months

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Objective Tumor Response

Grade 3 or higher adverse events were graded by CTC AE v 4.

Number of Participants With Grade 3 or Higher Adverse Events

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1

Progression-free Survival

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Overall Survival

Overall Study

Linda Gedeon on behalf of William Brady, PhD

Fallopian Tube Clear Cell Adenocarcinoma

Ovarian Clear Cell Adenocarcinoma

Recurrent Fallopian Tube Carcinoma

Recurrent Ovarian Carcinoma

Recurrent Primary Peritoneal Carcinoma

Cabozantinib S-malate

Laboratory Biomarker Analysis

Anchorage Radiation Therapy Center

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Regional Hospital

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

University of Arizona Cancer Center at Saint Joseph's

Saint Joseph's Hospital and Medical Center

CHI Saint Vincent Cancer Center Hot Springs

Kaiser Permanente-Anaheim

Sutter Auburn Faith Hospital

Sutter Cancer Centers Radiation Oncology Services-Auburn

Kaiser Permanente-Baldwin Park

Kaiser Permanente-Bellflower

Alta Bates Summit Medical Center-Herrick Campus

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Mills-Peninsula Medical Center

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Eden Hospital Medical Center

Sutter Davis Hospital

Kaiser Permanente-Fontana

Kaiser Permanente - Harbor City

Kaiser Permanente-Irvine

Kaiser Permanente Los Angeles Medical Center

Kaiser Permanente-Cadillac

Memorial Medical Center

Palo Alto Medical Foundation-Camino Division

Palo Alto Medical Foundation-Gynecologic Oncology

Sutter Cancer Research Consortium

Palo Alto Medical Foundation Health Care

Kaiser Permanente - Panorama City

Kaiser Permanente-Riverside

Sutter Cancer Centers Radiation Oncology Services-Roseville

Sutter Roseville Medical Center

Sutter Medical Center Sacramento

Kaiser Permanente-San Diego Mission

Kaiser Permanente-San Diego Zion

California Pacific Medical Center-Pacific Campus

Kaiser Permanente-San Marcos

Palo Alto Medical Foundation-Santa Cruz

Sutter Pacific Medical Foundation

Palo Alto Medical Foundation-Sunnyvale

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Sutter Solano Medical Center/Cancer Center

Kaiser Permanente-Woodland Hills

University of Florida Health Science Center - Gainesville

Northside Hospital

Northside Hospital-Forsyth

Northeast Georgia Medical Center-Gainesville

Hawaii Oncology Inc-Pali Momi

Pali Momi Medical Center

The Cancer Center of Hawaii-Pali Momi

Hawaii Cancer Care Inc-POB II

Hawaii Oncology Inc-POB I

Island Urology

Queen's Medical Center

Straub Clinic and Hospital

University of Hawaii Cancer Center

Hawaii Cancer Care Inc-Liliha

Hawaii Oncology Inc-Kuakini

Kuakini Medical Center

The Cancer Center of Hawaii-Liliha

Kapiolani Medical Center for Women and Children

Wilcox Memorial Hospital and Kauai Medical Clinic

Saint Luke's Mountain States Tumor Institute

Kootenai Medical Center

Saint Luke's Mountain States Tumor Institute - Fruitland

Saint Luke's Mountain States Tumor Institute - Meridian

Saint Luke's Mountain States Tumor Institute - Nampa

Kootenai Cancer Center

Kootenai Cancer Clinic

Saint Luke's Mountain States Tumor Institute-Twin Falls

Rush - Copley Medical Center

Saint Joseph Medical Center

Illinois CancerCare-Bloomington

Illinois CancerCare-Canton

Memorial Hospital of Carbondale

Illinois CancerCare-Carthage

Centralia Oncology Clinic

Northwestern University

Rush University Medical Center

Carle on Vermilion

Cancer Care Specialists of Illinois - Decatur

Decatur Memorial Hospital

Carle Physician Group-Effingham

Crossroads Cancer Center

Illinois CancerCare-Eureka

Illinois CancerCare-Galesburg

Western Illinois Cancer Treatment Center

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Illinois CancerCare-Kewanee Clinic

Illinois CancerCare-Macomb

Carle Physician Group-Mattoon/Charleston

Good Samaritan Regional Health Center

Illinois CancerCare-Ottawa Clinic

Radiation Oncology of Northern Illinois

Illinois CancerCare-Pekin

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum

National Cancer Institute (NCI)

NRG Oncology

Prothelial: Arm 1 Patients with oroesophageal mucositis (with pain, erythema, ulceration and difficult pain swallowing as prominent symptom/signs) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

Prothelial: Arm 2 Patients with gastric/small intestinal mucositis (delayed nausea, vomiting as prominent symptom/sign) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 3 Patients with lower GI mucositis develop chemoradiation diarrhea as their \ prominent symptom/sign[n=30]. Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 4 Patients anticipated to develop oroesophageal mucositis (with pain, erythema, ulceration and difficult pain swallowing as prominent symptom/signs) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and spit. (Phase IV)

ProThelial: Arm 5 Patients anticipated to develop gastric/small intestinal mucositis (delayed nausea vomiting as prominent symptom/sign) [n=30]. Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 6 Patients anticipated to develop chemoradiation diarrhea as their prominent symptom/sign [n=30]. Intervention: ProThelial 1.5 gram taken tid x 2 days then bid swish and swallow. (Phase I)

Oral Mucositis

Nausea

Vomiting

Diarrhea

August 2013, the FDA cleared the use of ProThelial, a polymerized high potency sucralfate paste, as a device for the management of oral mucositis.Standard potency non-polymerized sucralfate is not recommended by MASCC/ISOO for the treatment or prevention of mucositis, oral or alimentary. However high potency polymerized sucralfate has been associated with rapid amelioration and prevention of both oral and alimentary mucositis in a patient with advanced head neck cancer treated simultaneously with high dose chemo-radiation. High potency sucralfate is standard sucralfate polymerized into 'sucralfate sheets' that adhere and orderly layer upon the mucosa achieving and maintaining elevated concentrations of sucralfate long after the initial dose administration. Three hours following administration, high potency sucralfate maintains a 7 fold greater surface concentration of sucralfate on normal lining and a 23 fold greater concentration on inflamed, ulcerated mucosa.

ProThelial

Translational Medicine Research Center

ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy

Measures are to report the change from baseline in the OMAS used to assess patient in the prevention of oral mucositis by ProThelial (Phase IV)

Measures are to report the change from baseline in the OMAS used to assess patient in the treatment of oral mucositis by ProThelial (Phase IV)

PVAS is to be used to assess patient-reported pain of chemoradiation mucositis while under treatment with ProThelial (Phase IV)

DSVAS will be used to assess difficulty in swallowing in patients with chemoradiation mucositis under treatment with ProThelial (Phase I)

NCI Toxicity Grading of Alimentary Mucositis will be used to assess the degree of nausea, vomiting and diarrhea caused by chemoradiation (Phase I).

Ashley Downs Bioscience

Patients receive cabozantinib-s-malate PO QD on days 1-28.

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

Cabozantinib 60 mg oral daily continously

Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15

Paclitaxel

Total

Age, Customized

Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Event Free Survival

Toxicities will be characterized by their frequency and severity, grade 3 and above.

Grade 3 and above toxicities for participants on Cabozantinib 60 mg oral daily continously

Grade 3 and Above on Cabozantinib

Grade 3 toxicities for participants on Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15

Grade 3 and Above on Paclitaxel

Number of Participants With Grade 3 or Higher Adverse Events by Type

Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Response, Assessed According to RECIST Version 1.1

Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Percentage of Participants With CA125 Response.

The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.

The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

To Estimate the Response Duration Among Patients Who Respond.

c-Met Expression

c-MET Copy Number

Linda Gedeon on behalf of Michael Sill, PhD.

University of South Alabama Mitchell Cancer Institute

John Muir Medical Center-Concord Campus

Los Angeles County-USC Medical Center

USC / Norris Comprehensive Cancer Center

Cedars Sinai Medical Center

Gynecologic Oncology Associates-Newport Beach

University of Colorado Hospital

Hartford Hospital

The Hospital of Central Connecticut

Beebe Medical Center

Christiana Care Health System-Christiana Hospital

Mayo Clinic in Florida

Sarasota Memorial Hospital

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

University of Chicago Comprehensive Cancer Center

Indiana University/Melvin and Bren Simon Cancer Center

Saint Vincent Hospital and Health Care Center

Mary Greeley Medical Center

McFarland Clinic PC - Ames

McFarland Clinic PC-Boone

Mercy Cancer Center-West Lakes

Iowa Methodist Medical Center

Iowa-Wide Oncology Research Coalition NCORP

Medical Oncology and Hematology Associates-Des Moines

Medical Oncology and Hematology Associates-Laurel

Mercy Medical Center - Des Moines

Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

malate/kariess

Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

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