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

Running, not enrolling · Not applicable

Conditions studied: Gastrointestinal Neoplasms

In brief

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.

Key facts

Study ID

NCT01946854

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2013-07-16

Expected to finish

2028-01-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histological evidence of a metastatic well differentiated or moderately differentiated mucinous appendiceal epithelial neoplasm (AEN).
• Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP).
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Age >/= 18 years old.
• 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.
• Adequate bone marrow function as evidenced by: Hemoglobin >/= 9.0 g/dl; Platelet >/= 75,000 cells/mm\^3; Absolute neutrophil count >/= 1000/mm\^3.
• 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.
• Patients must agree to participate and be able to understand and provide informed consent to participate in the trial.

You may not qualify if…

• 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.
• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment.
• The presence of complete or partial bowel obstruction based upon clinical assessment.
• Ongoing use of total parental nutrition.
• The presence of a concurrent non-appendiceal metastatic cancer.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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