Clinical Trial: Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prospective Randomized Phase II Trial of Pazopanib (NSC #737754) Versus Placebo in Patients With Progressive Carcinoid Tumors

Brief Summary: This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) will be compared between patients randomized to treatment with pazopanib (pazopanib hydrochloride) versus placebo.

SECONDARY OBJECTIVES:

I. Overall survival will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms.

III. Progression free survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.

IV. PFS at 6 months and 12 months will be estimated within each treatment arm. V. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm.

VI. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA.

VII. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo.

TERTIARY OBJECTIVES:

I. Average time to submission of scans to the Imaging Core Laboratory (ICL) and average ICL "turn-around" time will be estimated.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Progression-free survival [ Time Frame: From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years ]

PFS will be estimated within treatment arm using the Kaplan-Meier method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response (DR) for the subset of patients with a confirmed CR or PR [ Time Frame: From first documented evidence of CR or PR until first documented disease progression or death from any cause, assessed up to 5 years ]
    DR will be summarized descriptively using Kaplan-Meier medians and quartiles.
  • Objective response rate (ORR), defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 criteria [ Time Frame: Up to 5 years ]
    The exact binomial confidence interval will be used to estimate ORR.
  • Overall survival (OS) [ Time Frame: From randomization until death from any cause, assessed up to 5 years ]
    OS will be estimated by the Kaplan-Meier method within each treatment arm.
  • Time to second progression for patients who crossover from placebo to active therapy [ Time Frame: Up to 5 years ]
  • Time to treatment failure [ Time Frame: From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years ]


Original Secondary Outcome:

  • Objective response rate (ORR), defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 criteria [ Time Frame: Up to 5 years ]
    The exact binomial confidence interval will be used to estimate ORR.
  • Overall survival (OS) [ Time Frame: From randomization until death from any cause, assessed up to 5 years ]
    OS will be estimated by the Kaplan-Meier method within each treatment arm.
  • Duration of response (DR) for the subset of patients with a confirmed CR or PR [ Time Frame: From first documented evidence of CR or PR until first documented disease progression or death from any cause, assessed up to 5 years ]
    DR will be summarized descriptively using Kaplan-Meier medians and quartiles.
  • Time to treatment failure (TTF) [ Time Frame: From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years ]
  • Time to second progression for patients who crossover from placebo to active therapy [ Time Frame: Up to 5 years ]


Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 24, 2013
Date Started: June 2013
Date Completion:
Last Updated: May 11, 2017
Last Verified: April 2017