A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma

Inclusion Criteria:

1. Age 18 years and above. There will be no upper age restriction

2. ECOG performance status ≤ 2

3. Participants must have histologically confirmed diagnosis of unresectable locallymetastatic appendiceal adenocarcinoma

4. Metastatic disease in the peritoneal cavity and not a candidate for cytoreductivesurgery

5. Participants must have adequate organ and marrow function as defined below: leukocytes ≥3000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥75,000/mcLtotal bilirubin ≤ institutional upper limit of normal (ULN) creatinine ≤ 1.5Xinstitutional ULN

6. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBVviral load must be undetectable on suppressive therapy, if indicated

7. Participants with a history of hepatitis C virus (HCV) infection must have beentreated and cured. For participants with HCV infection who are currently ontreatment, they are eligible if they have an undetectable HCV viral load

8. Participants with metastases outside the peritoneal cavity are not eligible forenrollment

9. Participants with a prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of the investigational regimen are eligible for this trial

10. The effects of PTX on the developing human fetus are unknown. For this reason, andbecause Taxane agents as well as other therapeutic agents used in this trial areknown to be teratogenic, women of child-bearing potential and men must agree to useadequate contraception (hormonal or barrier method of birth control; abstinence)prior to study entry and for the duration of study participation. (Refer toPregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). Thisincludes all female patients, between the onset of menses (as early as 8 years ofage) and 55 years unless the patient presents with an applicable exclusionary factorwhich may be one of the following:

11. Postmenopausal (no menses in greater than or equal to 12 consecutive months)

12. History of hysterectomy or bilateral salpingo-oophorectomy

13. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausalrange, who have received Whole Pelvic Radiation Therapy)

14. History of bilateral tubal ligation or another surgical sterilization procedureApproved methods of birth control are as follows: Hormonal contraception (i.e.,birth control pills, injection, implant, transdermal patch, vaginal ring),Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner postvasectomy, Implantable or injectable contraceptives, and condoms plusspermicide. Not engaging in sexual activity for the total duration of the trialand the drug washout period is an acceptable practice; however periodicabstinence, the rhythm method, and the withdrawal method are not acceptablemethods of birth control. Should a woman become pregnant or suspect she ispregnant while she or her partner is participating in this study, she shouldinform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequatecontraception prior to the study, for the duration of study participation, and 4months after completion of paclitaxel administration.

15. Ability to understand and the willingness to sign a written informed consentdocument

14. English and non-English-speaking participants

Exclusion Criteria:

1. Active infection such as pneumonia or wound infections that would preclude protocoltherapy

2. Participants with unstable angina or New York Heart Association (NYHA) Grade II orgreater congestive heart failure

3. Participants deemed unable to comply with study and/or follow-up procedures (i.e.,cognitive impairment)

4. Participants with a known hypersensitivity to protocol systemic chemotherapy thatwas life-threatening, required hospitalization or prolongation of existinghospitalization, or resulted in persistent or significant disability or incapacity

5. Previous surgery that would preclude safe diagnostic laparoscopy with port placement

6. Participants who have not recovered from adverse events (AE) due to prioranti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception ofalopecia

7. Participants who are receiving any other investigational agents

8. Participants with metastases outside the peritoneal cavity

9. History of allergic reactions attributed to compounds of similar chemical orbiologic composition to PTX or other agents used in study

10. Participants with psychiatric illness/social situations that would limit compliancewith study requirements Participants who are pregnant