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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
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Study 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
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My cancer is a specific type from the appendix and has spread.
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My scans show I have mucinous peritoneal carcinomatosis.
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I am not a candidate for surgery to remove all visible cancer.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My blood tests show normal levels of hemoglobin, platelets, and neutrophils.
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I am not pregnant or breastfeeding and agree to use birth control during and after treatment.
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I agree to participate and understand the consent form.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~20090

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,944 Previous Clinical Trials
1,775,350 Total Patients Enrolled
Keith F. Fournier, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this medical experiment?

"Affirmative. clinicaltrials.gov hosts records attesting to the efficacy of this medical trial which began on July 1st 2013, and was most recently updated on August 29th 2022. This study is currently seeking 30 patients from a single site."

Answered by AI

Is this research still actively recruiting participants?

"Affirmative. The records on clinicaltrials.gov demonstrate that this medical trial is actively seeking participants, with the initial posting being made in July 2013 and revised most recently in August 2021. Thirty individuals are needed at a single location to complete this research project."

Answered by AI
~4 spots leftby Jul 2025