Clinical Trial: Crossover Trial of Systemic Chemotherapy in Patients With Metastatic Well-Differentiated Mucinous Appendiceal Adenocarcinomas With Pseudomyxoma Peritonei

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Crossover Trial of Systemic Chemotherapy in Patients With Metastatic Well-Differentiated Mucinous Appendiceal Adenocarcinomas With Pseudomyxoma Peritonei

Brief Summary: Appendiceal cancer is a rare disease that does not cause many symptoms. As such, doctors are not sure if chemotherapy actually has an effect on the disease. The goal of this clinical research study is to learn more about the effects that chemotherapy may have on appendiceal cancer.

Detailed Summary:

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (cohorts):

  • If you are in Cohort A, you will first be observed for 6 months, then you will receive chemotherapy for 6 months.
  • If you are in Cohort B, you will first receive chemotherapy for 6 months, then you will be observed for 6 months.

You will have an equal chance of being assigned to either cohort. No matter which cohort you are in, the type of chemotherapy you receive will depend on the standard of care for the disease and what your doctor thinks is in your best interest. You will sign a separate consent form for chemotherapy that explains how the drug is given, as well as its risks and benefits.

Study Visits:

Every 3 months (+/- 2 weeks) for 12 months:

  • You will have a physical exam, including measurement of your weight and blood pressure.
  • Your performance status will be recorded.
  • Blood (about 2 tablespoons) will be drawn for routine tests.
  • You will complete the 3 questionnaires about your quality of life.
  • You will have an MRI or a CT scan to check the status of the disease.

Length of Stud:

You will be on study for up to 12 months. You will no longer be able to take part in this study if the disease gets worse, if intolerab
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Tumor Growth Rate [ Time Frame: 6 months ]

Primary objective is to determine if difference in tumor growth rate for each patient, as measured by mpRECIST, between observation and systemic chemotherapy periods is ≥5%. Growth rate determined as the percent reduction from the start of the period to the 6 month measurement in that period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: September 12, 2013
Date Started: July 2013
Date Completion:
Last Updated: October 7, 2016
Last Verified: October 2016