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Chemotherapy

Chemotherapy for Appendiceal Cancer

N/A
Waitlist Available
Led By Keith F. Fournier, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP).
Age >/= 18 years old.
Must not have
The presence of complete or partial bowel obstruction based upon clinical assessment.
Ongoing use of total parental nutrition.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will test how effective chemotherapy is in treating appendiceal cancer.

Who is the study for?
This trial is for adults with a rare type of appendiceal cancer that has spread and isn't suitable for complete surgical removal. Participants must have specific blood cell counts, not be pregnant or breastfeeding, able to answer quality-of-life questionnaires, and agree to use effective contraception.Check my eligibility
What is being tested?
The study aims to understand the effects of systemic chemotherapy on metastatic well-differentiated mucinous appendiceal adenocarcinomas with pseudomyxoma peritonei. It involves patients completing questionnaires to assess their quality of life during treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, systemic chemotherapy can generally cause fatigue, nausea, hair loss, increased risk of infection due to lowered immunity, and other organ-specific issues depending on the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My scans show I have mucinous peritoneal carcinomatosis.
Select...
I am 18 years old or older.
Select...
My blood tests show normal levels of hemoglobin, platelets, and neutrophils.
Select...
My cancer is a specific type from the appendix and has spread.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a blockage in my intestines.
Select...
I am currently on IV nutrition.
Select...
I have cancer that has spread from its original site, but it's not appendiceal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Growth Rate

Side effects data

From 2019 Phase 2 trial • 60 Patients • NCT02060370
83%
Fatigue
76%
Diarrhea
61%
Platelet count decreased
58%
White blood cell decreased
54%
Hand-foot syndrome
54%
Mucositis oral
54%
Anemia
46%
Dysgeusia
44%
Nausea
41%
Rash
39%
Proteinuria
39%
Neutrophil count decreased
36%
Creatinine increased
32%
Aspartate aminotransferase increased
27%
Hypertension
25%
Hypothyroidism
24%
Vomiting
22%
Dyspepsia
20%
Hypoalbuminemia
20%
Anorexia
20%
Dyspnea
20%
Skin hypopigmentation
19%
Alanine aminotransferase increased
17%
Watering eyes
15%
Edema
14%
Weight loss
14%
Oral dysesthesia
14%
Epistaxis
14%
Pruritus
12%
Hyperglycemia
12%
Gastroesophageal reflux disease
12%
Lymphocyte count decreased
12%
Hypocalcemia
10%
Blood bilirubin increased
10%
Dysesthesia
10%
Alkaline phosphatase increased
10%
Constipation
10%
Headache
8%
Hyponatremia
8%
TSH increased
7%
Dry skin
7%
Anal mucositis
7%
Hypomagnesemia
7%
Hair hypopigmentation
7%
Myalgia
7%
Dry mouth
7%
Non-cardiac chest pain
7%
Paresthesia
5%
Bloating
5%
Thromboembolic event
5%
Alopecia
5%
CD4 lymphocytes decreased
5%
Hyperkalemia
5%
Thrombotic thrombocytopenic purpura
5%
Abdominal pain
5%
Hemoglobinuria
2%
Dehydration
2%
Vascular access complication
2%
Hypophosphatemia
2%
Gout
2%
Pancreatic insufficiency
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sunitinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Observation ArmExperimental Treatment1 Intervention
Patients observed for 6 months, then will receive chemotherapy for 6 months.
Group II: Chemotherapy GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaire
2014
Completed Phase 2
~19970

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Chemotherapy for gastrointestinal tumors primarily involves cytotoxic drugs that target rapidly dividing cells to inhibit their growth or induce cell death. These drugs disrupt DNA replication or damage cellular machinery necessary for cell division, effectively reducing tumor size and slowing disease progression. This is crucial for gastrointestinal tumor patients as it helps manage the high rates of cell division characteristic of these cancers, allowing for better disease control and informed treatment decisions.
Emerging therapeutic options for platinum-sensitive ovarian cancer patients.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,249 Total Patients Enrolled
Keith F. Fournier, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~2 spots leftby Jul 2025
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