Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis

NCT02420509 | Terminated DMC

• 1 other identifier: 150295
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if postoperative chemotherapy in patients with high-grade appendix cancer after surgery improves outcomes. The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with bevacizumab. These drugs are approved for use in people with colon cancer, and they are used at UCSD for some patients with appendix cancer. The purpose of this study is to explore the safety and efficacy of the postoperative chemotherapy treatment on cancer.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  PFS will be measured from the time of the start of postoperative chemotherapy until disease progression or death during the total study period (four years)

  4 years

Secondary Outcomes (3)

• Overall Survival

  4 years

• Safety and Feasibility

  Safety and feasibility of the chemotherapy regimen will be measured from the time of the start of postoperative chemotherapy until completion of chemotherapy (one year)

• Quality of life will be measured by the Functional Assessment of Cancer Therapy

  Quality of life will be measured from prior to surgery until study completion (four years)

Study Arms (1)

systemic chemotherapy after CRS/HIPEC

Single-arm, prospective study of systemic chemotherapy after CRS/HIPEC. Subjects will be given twelve months of 5-FU or capecitabine with bevacizumab starting 4-8 weeks after surgery. CTRI Biostatistics Core personnel will assist in conducting analyses using the latest version of R (R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org/).

Drug: systemic chemotherapy

Interventions

systemic chemotherapy DRUG

twelve months of 5-FU or capecitabine with bevacizumab starting 4-8 weeks after surgery

Also known as: 5-FU, LEUCOVORIN, CAPECITABINE, BEVACIZUMAB

systemic chemotherapy after CRS/HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects are those with peritoneal carcinomatosis secondary to high-grade appendiceal cancer who have undergone complete cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), open or minimally invasive (laparoscopic or robotic), who plan to receive 12 months of 5-fluorouracil OR Capecitabine (Xeloda®), with Bevacizumab (Avastin®) for 12 months, with biochemical and radiologic surveillance.

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent.
• High-grade peritoneal carcinomatosis from appendiceal adenocarcinoma.
• Moderate or poorly-differentiated adenocarcinoma, signet ring cell carcinoma or "high-grade" carcinoma (in primary tumor or extra-appendiceal metastases) as designated by standardized pathologic testing.23,24
• May be initially determined from pre-CRS/HIPEC tumor pathology (for screening purposes), but must be confirmed with pathology from resected tumors as part of CRS/HIPEC.
• Have had complete (CC-0 or CC-1) CRS with HIPEC open or minimally invasive (laparoscopic or robotic)
• Have received or plan to receive 12 months of postoperative chemotherapy, starting no sooner than 4 weeks and no longer than 16 weeks after CRS/HIPEC, consisting of:
• fluorouracil (Adrucil®) 400 mg/m2 IV bolus then 2400 mg/m2 IV continuous infusion x 46hrs, leucovorin (Leucovorin Calcium) 20 mg/m2 IV bolus and bevacizumab (Avastin®) 5 mg/kg IV every two weeks for a total of 12 months (26 cycles); OR
• Capecitabine (Xeloda®) 1250 mg/m2 PO twice daily for 14 days, with 7-day break, bevacizumab (Avastin®) 7.5 mg/kg IV every three weeks, for a total of 12 months (17 cycles).
• Have received or plan to receive standard clinical, biochemical and radiographic surveillance, consisting of:
• Adverse event assessments every chemotherapy cycle and at the end of treatment
• CEA, CA19-9 and CA 125
• i) Every 1 month x 1 year (during treatment), then ii) Every 1 month x 6 months, then iii) Every 3 months x 1.5 years, then iv) Every 6 months x 1 year c) CT chest, abdomen and pelvis or MRI i) Every 3 months x 1 year (during treatment), then ii) Every 3 months x 1 year, then iii) Every 6 months x 1 year, then iv) Every 12 months x 1 year
• Age \> 18 years old
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Appendix A).
• Adequate organ and bone marrow function as defined below:

You may not qualify if:

• Current or anticipated use of other investigational agents.
• Patients who have received systemic chemotherapy or radiotherapy within two months prior to first scheduled cycle of postoperative chemotherapy.
• Patients who are less than 4 weeks from CRS/HIPEC or have insufficient recovery from surgical-related trauma or wound healing as determined by the patient's surgeon.
• History of hypersensitivity reaction specifically attributed to compounds of similar chemical or biologic composition to 5-FU, leucovorin, capecitabine or bevacizumab.
• History of deep venous thrombosis (DVT) or pulmonary embolism (PE).
• Concurrent active or measurable malignancies, except basal cell carcinoma or squamous cell carcinoma of the skin.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
• Known diagnosis of human immunodeficiency virus (HIV) infection.
• Incarcerated patients.
• Pregnant or nursing women, due to the potential for congenital abnormalities and for this regimen to harm nursing infants.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093-0987, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Neoadjuvant Therapy; Fluorouracil; Leucovorin; Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joel M Baumgartner, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 20, 2015
• Study Start: August 27, 2015
• Primary Completion: February 9, 2017
• Study Completion: April 2, 2019
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)