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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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%

Mucositis oral

54%

Hand-foot syndrome

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%

Alkaline phosphatase increased

10%

Blood bilirubin increased

10%

Constipation

10%

Dysesthesia

10%

Headache

Hyponatremia

TSH increased

Dry skin

Anal mucositis

Hypomagnesemia

Hair hypopigmentation

Myalgia

Dry mouth

Non-cardiac chest pain

Paresthesia

Alopecia

Bloating

Thromboembolic event

CD4 lymphocytes decreased

Hyperkalemia

Thrombotic thrombocytopenic purpura

Abdominal pain

Hemoglobinuria

Dehydration

Vascular access complication

Hypophosphatemia

Gout

Pancreatic insufficiency

Urticaria

100%

80%

60%

40%

20%

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

~20090

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,751 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

Recent research and studies

clinicaltrials.govStudy

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

2013. "Crossover Trial of Systemic Chemotherapy in Patients With Metastatic Well-Differentiated Mucinous Appendiceal Adenocarcinomas With Pseudomyxoma Peritonei". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01946854.

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