Pazopanib in Treating Patients With Advanced Neuroendocrine Cancer
This phase II trial is studying how well pazopanib works in treating patients with advanced neuroendocrine cancer. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Metastatic Gastrointestinal Carcinoid Tumor
Multiple Endocrine Neoplasia Type 1
Multiple Endocrine Neoplasia Type 2
Pancreatic Polypeptide Tumor
Pulmonary Carcinoid Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Regional Gastrointestinal Carcinoid Tumor
Drug: Pazopanib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of GW786034 (Pazopanib) in Advanced Low-Grade or Intermediate-Grade Neuroendocrine Carcinoma|
- Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
- Plasma Trough Level of GW786034 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to 18 months. ] [ Designated as safety issue: No ]PFS is defined as the duration of time from start of treatment to time of progression or death.
- Change in Tumor Blood Flow Assessed by Functional CT [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Patients receive oral pazopanib hydrochloride 800 mg once daily on days 1-28.
Drug: Pazopanib hydrochloride
Given oral (PO)
I. Determine the objective response rate (complete and partial response) in patients with low- or intermediate-grade advanced neuroendocrine carcinoma treated with pazopanib hydrochloride.
I. Determine the progression-free survival of patients treated with this drug.
II. Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid tumors vs islet cell carcinoma).
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454363
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James Yao||M.D. Anderson Cancer Center|