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Trial record 5 of 19 for:    "Pseudomyxoma peritonei"

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

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ClinicalTrials.gov Identifier: NCT01946854
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Behavioral: Questionnaire Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Crossover Trial of Systemic Chemotherapy in Patients With Metastatic Well-Differentiated Mucinous Appendiceal Adenocarcinomas With Pseudomyxoma Peritonei
Actual Study Start Date : July 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Observation Arm
Patients observed for 6 months, then will receive chemotherapy for 6 months.
Behavioral: Questionnaire

Completion of 3 questionnaires at baseline and at final visit about quality of life, and 1 questionnaire about symptoms, diagnosis, treatment, prognosis, and patient's relationship with caregivers. These will take about 35-50 minutes to complete.

Completion of 3 quality of life questionnaires every 3 months for 1 year.


Active Comparator: Chemotherapy Group
Patients receive chemotherapy for 6 months, then observed for 6 months. The exact type of fluoropyrimidine-based chemotherapy is not mandated and final treatment decisions will be left to the medical oncologist who is administering the chemotherapy. All chemotherapy adjustments will be done by the treating medical oncologist according to standard of care.
Behavioral: Questionnaire

Completion of 3 questionnaires at baseline and at final visit about quality of life, and 1 questionnaire about symptoms, diagnosis, treatment, prognosis, and patient's relationship with caregivers. These will take about 35-50 minutes to complete.

Completion of 3 quality of life questionnaires every 3 months for 1 year.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histological evidence of a metastatic well differentiated or moderately differentiated mucinous appendiceal epithelial neoplasm (AEN).
  2. Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP).
  3. Patients must not be considered a candidate for a complete surgical cytoreductive surgery. This determination will be made through either discussion at MD Anderson peritoneal surface malignancy multidisciplinary review or consultation with MD Anderson peritoneal surgeon.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
  5. Age >/= 18 years old.
  6. Patients must be able to understand and provide answers to the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/OV-28 QOL questionnaires in order to participate in the trial.
  7. Adequate bone marrow function as evidenced by: Hemoglobin >/= 9.0 g/dl; Platelet >/= 75,000 cells/mm^3; Absolute neutrophil count >/= 1000/mm^3.
  8. Women must not be pregnant or lactating. Women of childbearing potential must have a negative Beta-HCG serum pregnancy test and agree to refrain from breast-feeding, as specified in the informed consent given the unknown risk of teratogenicity of agents in the study. Patients of childbearing potential agree to use an effective form of contraception during chemotherapy and for 90 days following the last chemotherapy treatment.
  9. Patients must agree to participate and be able to understand and provide informed consent to participate in the trial.

Exclusion Criteria:

  1. Concurrent uncontrolled medical illness that is deemed by the investigator to have potential to interfere with the delivery of chemotherapy for a six month time period.
  2. Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment.
  3. The presence of complete or partial bowel obstruction based upon clinical assessment.
  4. Ongoing use of total parental nutrition.
  5. The presence of a concurrent non-appendiceal metastatic cancer.

Information from the National Library of Medicine

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): NCT01946854


Contacts
Contact: Keith F. Fournier, MD 713-792-8826

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Keith F. Fournier, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01946854     History of Changes
Other Study ID Numbers: 2012-1050
NCI-2015-00850 ( Registry Identifier: NCI CTRP )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal
Metastatic Well-differentiated Mucinous Appendiceal Adenocarcinomas with Pseudomyxoma Peritonea
Appendiceal cancer
Surgically unresectable
Chemotherapy
Observation
Questionnaires

Additional relevant MeSH terms:
Pseudomyxoma Peritonei
Adenocarcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Cystic, Mucinous, and Serous