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Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis


Phase 1
N/A
N/A
Not Enrolling
Both
Peritoneal Cancer

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Trial Information

Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis


The Study Drugs:

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.

Oxaliplatin is designed to keep new cancer cells from growing

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.

Study Drug Dose Levels:

Up to 12 study drug dose levels will be tested in this study. Participants will be enrolled
in groups of 3. The first 3 participants will be enrolled at the lowest dose level. If
there are no intolerable side effect seen, the next 3 participants will be enrolled into the
next higher dose level. This will continue until acceptable dose levels of the study drugs
are found. The dose level that you are assigned to will depend on when you enroll on this
study. You will receive the same dose level for the entire study unless you develop side
effects, in which case doses of the drugs will be decreased by your doctor.

Drug Administration:

If you agree to participate in this study, you will have a catheter placed in your abdomen
before receiving study drug. A catheter is a sterile flexible tube that will be placed
while you are under local anesthesia. Your doctor will explain this procedure to you in
more detail, and you will be required to sign a separate consent form.

On Day 1, you will receive bevacizumab followed by paclitaxel through a needle in your vein
over 24 hours.

On Day 2, after you have completed the paclitaxel infusion, you will be given about 1 quart
of fluid containing oxaliplatin into the abdomen through the catheter over 15 minutes.

On Day 8, you will be given about 1 quart of fluid containing paclitaxel into the abdomen
through the catheter over 15 minutes.

Every 21 days is called a study "cycle."

Study Visits:

During each cycle, you will see your doctor in his office to make sure that you are still
eligible to receive study drugs.

- Blood (about 1 tablespoon) will be drawn for routine tests each day during
hospitalization and then once a week as an outpatient.

- A urine sample will be collected once each cycle for routine tests.

- You will have scans such as a chest x-ray, CT, MRI, Positron emission tomography (PET),
and/or PET/CT scan after every 2 cycles (6 weeks) or earlier if the study doctor thinks
it is in your best interest, or the cancer gets worse. These scans are to check the
status of the disease. If the study doctor thinks it is more appropriate for you,
other types of scans may need to be performed. The study doctor will discuss these
scans with you, and you may be asked to sign a separate consent form.

Length of Study:

You will be taken off study if the disease gets worse or intolerable side effects occur.

End-of-Study Visit:

If you are taken off study, you will be asked to have an end-of-study visit. At this visit,
the following tests will be performed:

- Blood (about 1 tablespoon) and urine will be collected for routine tests.

- You will have repeat scans such as a chest x-ray, CT, MRI, PET, and/or PET/CT scan to
check the status of the disease. If the study doctor thinks it is more appropriate
for you, other types of scans may need to be performed. The study doctor will discuss
these scans with you, and you may be asked to sign a separate consent form.

This is an investigational study. Paclitaxel, oxaliplatin, and bevacizumab are FDA-approved
drugs, but their use in this study is investigational. Up to 72 patients will take part in
this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients must have advanced peritoneal carcinomatosis: they have either a disease
where there is no established standard of care therapy or have failed one or more
prior therapy. These include, but not limited to, recurrent epithelial ovarian
cancer, advanced endometrial cancer, advanced gastric cancer, advanced colorectal
cancer, and advanced primary peritoneal mesothelioma without significant chest
involvement. Previous intraperitoneal therapy with different agents is allowed as
long as their diseases have progressed.

2. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status < or
= 2 (0-2).

3. Patients must have normal organ and marrow function as defined below: Absolute
neutrophil count > or = 1,500/mcL Platelets > or = 100,000/mcL Total bilirubin < or =
2.0 and alanine aminotransferase (ALT) <2.5 * the institutional upper limit of
normal; Creatinine < or = 2.0 mg/dL or creatinine clearance > or = 40mL/min/1.73m2.

4. Patients must be able to understand and the willingness to sign an Institutional
Review Board (IRB)-approved written informed consent document.

5. Patients must have evidence of peritoneal carcinomatosis that is evaluable by
computer tomography (CT) or magnetic resonance imaging (MRI).

6. In the clinical judgment of the investigator, patients must have adequate potential
intraperitoneal fluid distribution with no gross fluid loculations and adhesions that
would significantly affect intraperitoneal drug distribution. This determination may
be made based on documented clinical, imaging or laboratory assessment.

7. Patients must have prothrombin time (PT)/ partial thromboplastin time (PTT) within
1.2 * the institutional upper limit of normal or < 3 * the institutional upper limit
of normal on anticoagulants.

8. Patients must have resting blood pressure no greater than 140 mmHg(systolic) or 90
mmHg (diastolic) for eligibility. Initiation or adjustment of blood pressure
medication is permitted prior to study entry.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable
angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis,
or psychiatric illness/social situations that would limit compliance with study
requirements.

2. History of allergic reactions to the study drugs or their analogs.

3. Failure to recover from any prior surgery within 4 weeks of study entry.

4. Pregnant or lactating. Women of childbearing potential must have a negative serum
pregnancy test performed within 7 days prior to the start of treatment. Women of
childbearing potential and men must agree to use adequate contraception (barrier
method of birth control) prior to study entry, for the duration of study
participation and for at least 3 months after the last treatment.

5. Any treatment specific for tumor control within 3 weeks of study drugs; or within 2
weeks if cytotoxic agents were given weekly (within 6 wks for nitrosoureas or
mitomycin C), or within 5 half-lives for target agents with half lives and
pharmacodynamic effects lasting less than 5 days (that include but are not limited to
erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to
recover from the toxic effect of any therapy prior to study entry.

6. Serious non-healing wound, ulcer, bone fracture (including abdominal fistula,
gastrointestinal perforation or intra-abdominal abscess), or history of bleeding
diathesis.

7. History of radiotherapy to the abdominal and pelvic regions or history of multiple
abdominal surgeries that contraindicates this protocol therapy.

8. Urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria
on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must
demonstrate
9. Grade 2 or greater neuropathy, and history of brain or leptomeningeal metastases that
significantly increase risks of intracranial bleeding.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Continual assessment during each 21 day cycle

Safety Issue:

Yes

Principal Investigator

Apostolia Tsimberidou, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-1068

NCT ID:

NCT00491855

Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Peritoneal Cancer
  • Advanced Peritoneal Carcinomatosis
  • Peritoneal Cancer
  • Bevacizumab
  • Avastin
  • vascular endothelial growth factor
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
  • Oxaliplatin
  • Eloxatin
  • Paclitaxel
  • Taxol
  • Peritoneal Neoplasms
  • Carcinoma

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030