Overview

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

Status:
Active, not recruiting
Trial end date:
2024-05-31
Target enrollment:
0
Participant gender:
All
Summary
This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
Bevacizumab
Capecitabine
Oxaliplatin
Criteria
Inclusion Criteria:

- Histological Diagnosis: Patients must have a histologically documented peritoneal
carcinomatosis from either colorectal or appendiceal adenocarcinoma.

- Prior Surgical Debulking: Patients must have undergone debulking surgery with
peritonectomy and have been allowed at least 4 weeks to recover prior to receiving
chemotherapy.

- Port Placement: Intraperitoneal ports may be placed during or at any time separate
from surgical debulking. Provided the patient has been allowed at least 4 weeks to
recover from surgical debulking, no additional recovery time is required for port
placement.

- Active port: Patients must undergo a peritoneal scan documenting at least one working
intraperitoneal port prior to receiving chemotherapy.

- Patients may have received prior chemotherapy.

- Age: Patients must be ≥18 years of age. Because no dosing or toxicity data are
currently available on the use of oxaliplatin in patients <18 years of age.

- Performance Status: (Eastern cooperativeOncology Group) ECOG 0-2.

- Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled
intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmias.

- Informed Consent: All patients must be consented prior to chemotherapy. The patient
should not have any serious medical of psychiatric illness that would prevent either
the giving of informed consent or the receipt of treatment.

- Hematological Status:

- absolute neutrophil count ≥1,500/mm³

- platelet count ≥100,000/mm³

- hemoglobin ≥8 g/dl.

- Hepatic function:

- Total bilirubin must be <2X the institutional upper limit of normal (ULN)

- Transaminases (SGOT and/or SGPT) must be ≤3X the institutional upper limit of
normal (ULN)

- Alkaline phosphatase must be ≤4X the institutional upper limit of normal (ULN)

- Renal Function: Patients must have adequate renal function prior to chemotherapy
defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml.min/1.73 m² for
patients with creatinine levels above 2.0 mg/dl.

Exclusion Criteria:

- Pregnant or breast feeding: For all sexually active patients, the use of adequate
contraception (hormonal or barrier method of birth control) will be required during
therapy, prior to study entry, and for the duration of study participation.
Non-pregnant status will be determined in all women of childbearing potential.

- Prior history of hypersensitivity reactions to oxaliplatin, bevacizumab, 5-FU or
capecitabine.

- Gastrointestinal ailments that may alter the absorption of oral medications (i.e.
bowel obstruction, short-gut syndrome).

- Patients receiving antiretroviral therapy Highly Active Anti Retroviral Treatment
(HAART) for HIV infection are excluded from the study because of possible
pharmacokinetic interactions. Appropriate studies will be undertaken in patients
receiving HAART therapy, when indicated.

- Patients with Grade 2 or higher peripheral neuropathy.