Anchorage Associates in Radiation Medicine |
Anchorage, Alaska, United States, 98508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Anchorage Radiation Therapy Center |
Anchorage, Alaska, United States, 99504 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Alaska Breast Care and Surgery LLC |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Alaska Oncology and Hematology LLC |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Alaska Women's Cancer Care |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Anchorage Oncology Centre |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Katmai Oncology Group |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Providence Alaska Medical Center |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Gary E. Goodman |
Kingman Regional Medical Center |
Kingman, Arizona, United States, 86401 |
Contact: Site Public Contact protocols@swog.org |
Principal Investigator: John A. Ellerton |
CHI Saint Vincent Cancer Center Hot Springs |
Hot Springs, Arkansas, United States, 71913 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Mission Hope Medical Oncology - Arroyo Grande |
Arroyo Grande, California, United States, 93420 |
Contact: Site Public Contact 916-851-2283 research@dignityhealth.org |
Principal Investigator: Richard L. Deming |
PCR Oncology |
Arroyo Grande, California, United States, 93420 |
Contact: Site Public Contact 702-384-0013 research@sncrf.org |
Principal Investigator: John A. Ellerton |
Providence Saint Joseph Medical Center/Disney Family Cancer Center |
Burbank, California, United States, 91505 |
Contact: Site Public Contact 818-847-4793 Najee.Boucher@providence.org |
Principal Investigator: Gary E. Goodman |
City of Hope Comprehensive Cancer Center |
Duarte, California, United States, 91010 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Marianna Koczywas |
City of Hope Antelope Valley |
Lancaster, California, United States, 93534 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Marianna Koczywas |
Fremont - Rideout Cancer Center |
Marysville, California, United States, 95901 |
Contact: Site Public Contact 530-749-4400 |
Principal Investigator: Jonathan W. Riess |
City of Hope Mission Hills |
Mission Hills, California, United States, 91345 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Marianna Koczywas |
University of California Davis Comprehensive Cancer Center |
Sacramento, California, United States, 95817 |
Contact: Site Public Contact 916-734-3089 |
Principal Investigator: Jonathan W. Riess |
Mission Hope Medical Oncology - Santa Maria |
Santa Maria, California, United States, 93444 |
Contact: Site Public Contact 916-851-2283 research@dignityhealth.org |
Principal Investigator: Richard L. Deming |
City of Hope South Pasadena |
South Pasadena, California, United States, 91030 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Marianna Koczywas |
City of Hope West Covina |
West Covina, California, United States, 91790 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Marianna Koczywas |
Penrose-Saint Francis Healthcare |
Colorado Springs, Colorado, United States, 80907 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Rocky Mountain Cancer Centers-Penrose |
Colorado Springs, Colorado, United States, 80907 |
Contact: Site Public Contact 303-777-2663 info@westernstatesncorp.org |
Principal Investigator: Richard L. Deming |
Porter Adventist Hospital |
Denver, Colorado, United States, 80210 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Mercy Medical Center |
Durango, Colorado, United States, 81301 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Southwest Oncology PC |
Durango, Colorado, United States, 81301 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Mountain Blue Cancer Care Center |
Golden, Colorado, United States, 80401 |
Rocky Mountain Cancer Centers-Lakewood |
Lakewood, Colorado, United States, 80228 |
Saint Anthony Hospital |
Lakewood, Colorado, United States, 80228 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Littleton Adventist Hospital |
Littleton, Colorado, United States, 80122 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Longmont United Hospital |
Longmont, Colorado, United States, 80501 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Rocky Mountain Cancer Centers-Longmont |
Longmont, Colorado, United States, 80501 |
Contact: Site Public Contact 303-777-2663 info@westernstatesncorp.org |
Principal Investigator: Richard L. Deming |
Parker Adventist Hospital |
Parker, Colorado, United States, 80138 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Rocky Mountain Cancer Centers-Parker |
Parker, Colorado, United States, 80138 |
Saint Mary Corwin Medical Center |
Pueblo, Colorado, United States, 81004 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Rocky Mountain Cancer Centers - Pueblo |
Pueblo, Colorado, United States, 81008 |
Rocky Mountain Cancer Centers-Thornton |
Thornton, Colorado, United States, 80260 |
Moffitt Cancer Center-International Plaza |
Tampa, Florida, United States, 33607 |
Contact: Site Public Contact 800-679-0775 canceranswers@moffitt.org |
Principal Investigator: Tawee Tanvetyanon |
Moffitt Cancer Center - McKinley Campus |
Tampa, Florida, United States, 33612 |
Contact: Site Public Contact 800-679-0775 canceranswers@moffitt.org |
Principal Investigator: Tawee Tanvetyanon |
Moffitt Cancer Center |
Tampa, Florida, United States, 33612 |
Contact: Site Public Contact 800-679-0775 canceranswers@moffitt.org |
Principal Investigator: Tawee Tanvetyanon |
Saint Alphonsus Cancer Care Center-Boise |
Boise, Idaho, United States, 83706 |
Contact: Site Public Contact 734-712-3671 stephanie.couch@stjoeshealth.org |
Principal Investigator: John M. Schallenkamp |
Saint Luke's Mountain States Tumor Institute |
Boise, Idaho, United States, 83712 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Gary E. Goodman |
Saint Alphonsus Cancer Care Center-Caldwell |
Caldwell, Idaho, United States, 83605 |
Contact: Site Public Contact 734-712-3671 stephanie.couch@stjoeshealth.org |
Principal Investigator: John M. Schallenkamp |
Kootenai Medical Center |
Coeur d'Alene, Idaho, United States, 83814 |
Contact: Site Public Contact 406-969-6060 mccinfo@mtcancer.org |
Principal Investigator: John M. Schallenkamp |
Walter Knox Memorial Hospital |
Emmett, Idaho, United States, 83617 |
Contact: Site Public Contact 734-712-3671 stephanie.couch@stjoeshealth.org |
Principal Investigator: John M. Schallenkamp |
Saint Luke's Cancer Institute - Fruitland |
Fruitland, Idaho, United States, 83619 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Gary E. Goodman |
Idaho Urologic Institute-Meridian |
Meridian, Idaho, United States, 83642 |
Contact: Site Public Contact 734-712-3671 stephanie.couch@stjoeshealth.org |
Principal Investigator: John M. Schallenkamp |
Saint Luke's Cancer Institute - Meridian |
Meridian, Idaho, United States, 83642 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Gary E. Goodman |
Saint Alphonsus Medical Center-Nampa |
Nampa, Idaho, United States, 83686 |
Contact: Site Public Contact 734-712-3671 stephanie.couch@stjoeshealth.org |
Principal Investigator: John M. Schallenkamp |
Saint Luke's Cancer Institute - Nampa |
Nampa, Idaho, United States, 83686 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Gary E. Goodman |
Kootenai Cancer Center |
Post Falls, Idaho, United States, 83854 |
Contact: Site Public Contact 406-969-6060 mccinfo@mtcancer.org |
Principal Investigator: John M. Schallenkamp |
Kootenai Cancer Clinic |
Sandpoint, Idaho, United States, 83864 |
Contact: Site Public Contact 406-969-6060 mccinfo@mtcancer.org |
Principal Investigator: John M. Schallenkamp |
Saint Luke's Cancer Institute - Twin Falls |
Twin Falls, Idaho, United States, 83301 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Gary E. Goodman |
Northwestern University |
Chicago, Illinois, United States, 60611 |
Contact: Site Public Contact 312-695-1301 cancer@northwestern.edu |
Principal Investigator: Nisha A. Mohindra |
Northwestern Medicine Lake Forest Hospital |
Lake Forest, Illinois, United States, 60045 |
Contact: Site Public Contact cancertrials@northwestern.edu |
Principal Investigator: Nisha A. Mohindra |
Medical Oncology and Hematology Associates-West Des Moines |
Clive, Iowa, United States, 50325 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Mercy Cancer Center-West Lakes |
Clive, Iowa, United States, 50325 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Alegent Health Mercy Hospital |
Council Bluffs, Iowa, United States, 51503 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
Principal Investigator: Richard L. Deming |
Greater Regional Medical Center |
Creston, Iowa, United States, 50801 |
Contact: Site Public Contact 308-398-6518 clinicaltrials@sfmc-gi.org |
October 1, 2018
|
October 3, 2018
|
December 8, 2020
|
August 9, 2018
|
November 30, 2021 (Final data collection date for primary outcome measure)
|
Progression-free survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic, assessed up to 2 years ]
|
Same as current
|
|
- Incidence of adverse events [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
- Response rate (complete response, partial response, confirmed and unconfirmed) [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
- Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
- Overall survival [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
|
- Incidence of adverse events [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher?s exact or Chi-squared test at the 1-sided 0.10 level.
- Response rate (complete response, partial response, confirmed and unconfirmed) [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher?s exact or Chi-squared test at the 1-sided 0.10 level.
- Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher?s exact or Chi-squared test at the 1-sided 0.10 level.
- Overall survival [ Time Frame: Up to 2 years ]
Binary proportions will be compared between the arms using either a Fisher?s exact or Chi-squared test at the 1-sided 0.10 level.
|
Not Provided
|
Not Provided
|
|
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery
|
A Randomized Phase II Trial of Carboplatin-Paclitaxel With or Without Ramucirumab in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
|
This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and 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. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.
|
PRIMARY OBJECTIVE:
I. To compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab.
SECONDARY OBJECTIVES:
I. To evaluate the frequency and severity of toxicity of carboplatin-paclitaxel with or without ramucirumab in this patient population.
II. To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms.
III. To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms.
IV. To compare overall survival between treatment arms.
ADDITIONAL OBJECTIVE:
I. To bank specimens for future research.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 1 year.
|
Interventional
|
Phase 2
|
Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
|
- Locally Advanced Thymic Carcinoma
- Metastatic Thymic Carcinoma
- Recurrent Thymic Carcinoma
- Unresectable Thymic Carcinoma
|
- Drug: Carboplatin
Given IV
Other Names:
- Blastocarb
- Carboplat
- Carboplatin Hexal
- Carboplatino
- Carboplatinum
- Carbosin
- Carbosol
- Carbotec
- CBDCA
- Displata
- Ercar
- JM-8
- Nealorin
- Novoplatinum
- Paraplatin
- Paraplatin AQ
- Paraplatine
- Platinwas
- Ribocarbo
- Drug: Paclitaxel
Given IV
Other Names:
- Anzatax
- Asotax
- Bristaxol
- Praxel
- Taxol
- Taxol Konzentrat
- Biological: Ramucirumab
Given IV
Other Names:
- Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B
- Cyramza
- IMC-1121B
- LY3009806
- Monoclonal Antibody HGS-ETR2
|
- Experimental: Arm A (ramucirumab, carboplatin, paclitaxel)
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
Interventions:
- Drug: Carboplatin
- Drug: Paclitaxel
- Biological: Ramucirumab
- Active Comparator: Arm B (carboplatin, paclitaxel)
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions:
- Drug: Carboplatin
- Drug: Paclitaxel
|
Not Provided
|
|
Recruiting
|
66
|
Same as current
|
November 30, 2022
|
November 30, 2021 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
|
Sexes Eligible for Study: |
All |
|
18 Years and older (Adult, Older Adult)
|
No
|
|
United States
|
|
|
NCT03694002
|
S1701 NCI-2017-02254 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1701 S1701 ( Other Identifier: SWOG ) S1701 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract )
|
Yes
|
Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Not Provided
|
Southwest Oncology Group
|
Southwest Oncology Group
|
National Cancer Institute (NCI)
|
Principal Investigator: |
Anne S Tsao |
Southwest Oncology Group |
|
Southwest Oncology Group
|
December 2020
|
|