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A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma

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Trial Information

A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer


- To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous
bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan
documenting function of intraperitoneal ports in patients with peritoneal
carcinomatosis of appendiceal or colorectal etiology.

- To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy
with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after
adequate surgical debulking and peritoneal scan documenting function of intraperitoneal
ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.

- To describe the progression rate, progression-free survival and overall survival in
patients treated with this regimen.


Inclusion Criteria:



- Patients must fulfill (or have previously met) the following eligibility requirements
prior to initiation of chemotherapy:

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

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

- 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.

- Inclusion of Women and Minorities: Entry to this study is open to both men and women
and to all racial and ethnic subgroups.

- 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, and 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after surgical debulking and peritoneal scan documenting functional of intraperitoneal ports in patients with peritoneal carcinomatosis

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Benjamin Tan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-0136 / 201107017

NCT ID:

NCT01061515

Start Date:

October 2011

Completion Date:

January 2019

Related Keywords:

  • Carcinoma
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110