Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03334409|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Metastatic Clear Cell Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v7 Unresectable Renal Cell Carcinoma||Drug: Ascorbic Acid Drug: Pazopanib Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Phase II Trial of Intravenous Ascorbic Acid (Vitamin C) as an Adjunct to Pazopanib in the First-Line or Post-Immunotherapy Setting for Metastatic or Unresectable Clear Cell Renal Cell Carcinoma (ccRCC)|
|Actual Study Start Date :||February 16, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Arm A (pazopanib hydrochloride, ascorbic acid)
Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Ascorbic Acid
Drug: Pazopanib Hydrochloride
Active Comparator: Arm B (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Pazopanib Hydrochloride
- Treatment failure-free rate [ Time Frame: At 40 weeks ]Treatment failure is defined as any of the following: radiographic disease progression, off-protocol treatment due to adverse event, initiation of alternative therapy (except metastasectomy post clinical benefit (complete response [CR], partial response [PR], or stable disease [SD] per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 to treatment), and death due to any cause.
- Overall survival [ Time Frame: From randomization to death due to any cause, assessed up to 3 years ]Will be estimated using the method of Kaplan-Meier and be compared using log rank tests.
- Progression free survival [ Time Frame: From start of study therapy to documentation of disease progression or death, whichever comes first, assessed up to 2 years ]Will be estimated using the Kaplan-Meier method.
- Overall response rate [ Time Frame: Up to 2 years ]Defined to be a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1.1. Will be compared using a Chi-Square test.
- Duration of time on pazopanib hydrochloride [ Time Frame: From initial dose of pazopanib hydrochloride until the date the patient is considered off-treatment for pazopanib hydrochloride or death, whichever comes first, assessed up to 3 years ]Will be described using descriptive statistics.
- Incidence of adverse events [ Time Frame: Up to 3 years ]Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events and toxicities will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event rates for grade 3 or higher adverse events, will be compared using Chi-Square tests between the 2 treatment arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334409
|United States, Florida|
|Mayo Clinic in Florida||Not yet recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Clinical Trials Referrals Office 855-776-0015 firstname.lastname@example.org|
|Principal Investigator: Richard W. Joseph|
|United States, Illinois|
|Peoria, Illinois, United States, 61615|
|Carle Cancer Center||Recruiting|
|Urbana, Illinois, United States, 61801|
|Contact: Melanie Grigsby 217-383-4076 email@example.com|
|Principal Investigator: Priyank P. Patel|
|United States, Iowa|
|Iowa-Wide Oncology Research Coalition NCORP||Recruiting|
|Des Moines, Iowa, United States, 50309|
|Contact: Andrea Zarling 515-241-3305 firstname.lastname@example.org|
|Principal Investigator: Joshua C. Lukenbill|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referrals Office 855-776-0015 email@example.com|
|Principal Investigator: Lance C. Pagliaro|
|Metro Minnesota Community Oncology Research Consortium||Recruiting|
|Saint Louis Park, Minnesota, United States, 55416|
|Contact: Elizabeth J. Wagner 953-993-1555 firstname.lastname@example.org|
|Principal Investigator: David M. King|
|United States, North Dakota|
|Sanford Medical Center Fargo||Recruiting|
|Fargo, North Dakota, United States, 58104|
|Contact: Melissa Burgard 701-234-2718 email@example.com|
|Principal Investigator: Preston D. Steen|
|United States, Ohio|
|Columbus NCI Community Oncology Research Program||Withdrawn|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Lance C Pagliaro||Academic and Community Cancer Research United|