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ACTIVE NOT RECRUITING

NCT01946854

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

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2013-07-16

Completion Date

2026-01-31

Last Updated

2025-11-18

Healthy Volunteers

Conditions

Gastrointestinal Neoplasms

Interventions

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.

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.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States