Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT04200443|
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : November 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Leiomyosarcoma Metastatic Soft Tissue Sarcoma Stage III Uterine Corpus Leiomyosarcoma AJCC v8 Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8 Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8 Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8 Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8 Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8 Unresectable Leiomyosarcoma Unresectable Soft Tissue Sarcoma||Drug: Cabozantinib Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Temozolomide||Phase 2|
I. To determine the progression-free survival (defined as complete response [CR]+partial response [PR]+stable disease [SD]) assessed at 12 weeks for subjects in Cohort 1 (Leiomyosarcoma Arm) treated with cabozantinib and temozolomide as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
I. To determine the overall response rate (defined as CR+PR) for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
II. To determine the clinical benefit rate (CR+PR+SD) for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
III. To evaluate the median progression free rate for subjects with combination of cabozantinib and temozolomide.
IV. To evaluate overall survival for subjects in Cohort 1 treated with a combination of cabozantinib and temozolomide.
V. To assess safety and tolerability for subjects treated with a combination of cabozantinib and temozolomide.
VI. To determine the overall response rate (defined as CR+PR) in Cohort 2 (other soft tissue sarcomas).
VII. To assess Quality of Life (QoL) and subject-reported outcomes as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the EuroQoL-Group Health Questionnaire (EQ-5D-5L).
I. To estimate the correlation of progression free rate (PFR) and overall survival (OS) to levels of sVEGFR2, PIGF, VEGF, HGF, sMET, VEGF-C, VEGF-D, and soluble AXL.
Patients receive cabozantinib orally (PO) once daily (QD) on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with progressive disease (PD) are followed up every 6 months for up to 2 years and patients without PD are followed up every 6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cabozantinib and Temozolomide in Patients With Unresectable or Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas|
|Actual Study Start Date :||January 14, 2020|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Treatment (cabozantinib, temozolomide)
Patients receive cabozantinib PO QD on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Progression-free survival (PFS) [ Time Frame: After the first 12 weeks of therapy ]PFS will be the time from the start of treatment to the time of progression, with progression defined as changes in Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined imaging, progression in non-target lesions as defined by RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
- Presence of response (Cohort 1) [ Time Frame: At weeks 6 and 12, then every 2 cycles up to 5 years ]Will be defined as complete response (CR) + partial response (PR).
- Clinical benefit rate (Cohort 1) [ Time Frame: At weeks 6 and 12, then every 2 cycles up to 5 years ]Will be defined as CR + PR + stable disease (SD).
- Median progression free rate [ Time Frame: Up to 5 years ]Will assess the time from the first dose of study treatment until progression based upon changes in RECIST 1.1, unequivocal clinical deterioration, or death from any cause.
- Overall survival (OS) (Cohort 1) [ Time Frame: Up to 2 years ]Will assess the time from the first dose of the study treatment until death from any cause, up to a maximum follow-up of two years.
- Incidence of adverse events [ Time Frame: From time of first treatment up to 5 years ]Will assess the presence of all toxicities outlined in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Subject-reported outcomes [ Time Frame: 5 years ]Will be assessed by the EuroQoL-Group Health Questionnaire (EQ-5D-5L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200443
|Contact: Mark Agulnikemail@example.com|
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Mark Agulnik 626-359-8111 firstname.lastname@example.org|
|Principal Investigator: Mark Agulnik|
|United States, Illinois|
|Northwestern University||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Seth Pollack, M.D. 312-503-5320 email@example.com|
|Principal Investigator: Seth Pollack, M.D.|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Varun Monga 319-384-9497 firstname.lastname@example.org|
|Principal Investigator: Varun Monga|
|United States, Missouri|
|Washington University School of Medicine||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Brian A. Van Tine 314-747-8475 email@example.com|
|Principal Investigator: Brian A. Van Tine|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: John A. Charlson 414-805-4600 firstname.lastname@example.org|
|Principal Investigator: John A. Charlson|
|Principal Investigator:||Mark Agulnik, MD||City of Hope Medical Center|