Know Cancer

forgot password

Feasibility of Carboplatin, Paclitaxel and Bevacizumab Neoadjuvant Therapy for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Phase 0
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Thank you

Trial Information

Feasibility of Carboplatin, Paclitaxel and Bevacizumab Neoadjuvant Therapy for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

This study is designed to determine the feasibility of administering neoadjuvant
carboplatin, paclitaxel, and bevacizumab without excessive dose modification or cycle delay
in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube
cancer. This study will also investigate the rate of optimal cytoreduction, response rate
and progression free and overall survival, and to assess the quality of life for patients
with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer treated
with neoadjuvant carboplatin, paclitaxel and bevacizumab.

Inclusion Criteria:

- Patients must have Suspected FIGO stage III or IV disease.

- Cytologic or histologic diagnosis of a carcinoma felt by the investigator to be
compatible with epithelial cancer of the ovary, fallopian tube, or primary peritoneum

- Patients must have a GOG Performance Status of 0, 1 or 2.

- Patients with prior anthracycline exposure must have a baseline MUGA or
echocardiogram prior to study entry.

- Patients must have adequate:

- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1500/υl, equivalent to Common Toxicity Criteria for Adverse Events v3.0 (CTCAE)
Grade 1. This ANC cannot have been induced or supported by granulocyte colony
stimulating factors.

- Platelets greater than or equal to 100,000/υl (CTCAE Grade 0-1).

- Hematocrit > 21%.

- Renal function: Creatinine < 1.5 x institutional upper limit of normal (ULN),
CTCAE Grade 1.

- Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE Grade 1).
SGOT (AST), SGPT (ALT), and alkaline phosphatase less than or equal to 2.5 x ULN
(CTCAE Grade 1).

- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE
Grade 1.

- Coagulation function: PT such that international normalized ratio (INR) is ≤ 1.5
(or an in-range INR, usually between 2 and 3, if a patient is on a stable dose
of therapeutic warfarin for management of venous thrombosis including pulmonary
thromboembolism) and a PTT < 1.2 times the upper limit of normal.

- Patients must have measurable disease. Patients may or may not have cancer-related

- Baseline CA-125 must be ≥ 70 units/mL.

- Patients must have met all pre-entry requirements.

- An approved informed consent and authorization permitting release of personal health
information must be signed by the patient or guardian.

- Eligible patients should be deemed as likely to be medically fit to undergo surgical
cytoreduction after 3 cycles of neoadjuvant chemotherapy by a surgical gynecologic

- Patients may receive estrogen +/- progestin replacement.

Exclusion Criteria:

- Patients should NOT have undergone any prior cancer directed surgery (exploration,
debulking, etc), with the exception of a minor procedure such as biopsy or cytology

- Patients who have received prior chemotherapy, immunotherapy, radiotherapy, hormonal
therapy or biologic therapy for their ovarian or primary peritoneal cancer are not

- Patients with borderline ovarian tumors, recurrent epithelial ovarian or primary
peritoneal cancer or non-epithelial ovarian cancer are not eligible.

- Patients with a CA125:CEA ratio <25.

- Patients with other cancers (other than non-melanoma skin cancer) within the last
five years.

- Patients with acute hepatitis or end stage liver disease.

- Patients with serious non-healing wound, ulcer or bone fracture. This includes
history of abdominal fistula or intra-abdominal abscess within 6 months. Patients
with granulating incisions healing by secondary intention with no evidence of fascial
dehiscence or infection are eligible but require weekly wound examinations.

- History of prior gastrointestinal perforation.

- Patients with evidence of abdominal free air not explained by paracentesis.

- Patients with signs or symptoms of gastrointestinal obstruction including those
receiving total parenteral nutrition (TPN), intravenous hydration or tube feeds.

- Patients with active bleeding or pathologic conditions that carry high risk of
bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
vessels by imaging, regardless of whether any chance of requiring vascular

- Patients with history or evidence upon physical examination of CNS disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
attack (TIA) or subarachnoid hemorrhage within six months of the first date of
treatment on this study. Patients with treated brain metastases can enter the study.
Treated brain metastases are defined as having no evidence of progression or
hemorrhage after treatment and no ongoing requirement for dexamethasone, as
ascertained by clinical examination and brain imaging (MRI or CT) during the
screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain
metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma
Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating
physician. Patients with CNS metastases treated by neurosurgical resection or brain
biopsy performed within 3 months prior to Day 1 will be excluded.

- Patients with clinically significant cardiovascular disease. This includes:

- Uncontrolled hypertension, defined as systolic > 140 mm Hg or diastolic > 90 mm

- Myocardial infarction or unstable angina within 6 months of day 1 prior to

- New York Heart Association (NYHA) Grade II or greater congestive heart failure.

- Serious cardiac arrhythmia requiring medication. This does not include atrial

- CTCAE Grade 3 or greater peripheral vascular disease.

- History of CVA within six months.

- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human or humanized antibodies including hypersensitivity to any component
of bevacizumab

- Patients with clinically significant proteinuria. Urine protein should be screened by
urine protein-creatinine ratio (UPCR). The UPCR has been found to correlate directly
with the amount of protein excreted in a 24 hour urine collection. Specifically, a
UPCR of 1.0 is equivalent to 1.0 grams of protein in a 24 hour urine collection.
Obtain at least 4 ml of a random urine sample in a sterile container (does not have
to be a 24 hour urine). Send sample to lab with request for urine protein and
creatinine levels (separate requests). The lab will measure protein concentration
(mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein
concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR < 1.0 to allow
participation in the study.

- Patients with hypertensive crises or hypertensive encephalopathy

- History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month
prior to day 1.

- Patients with or with anticipation of a non-study related invasive procedure defined
as followed:

- Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to the first date of bevacizumab.

- Major non-study related surgical procedure anticipated during the course of the

- Core biopsy within 7 days prior to first date of bevacizumab.

- Patients with a GOG Performance Status of Grade 3 or 4 are not eligible.

- Patients who are pregnant or nursing. Subjects of child-bearing age have to use
effective means of contraception.

- Patients under the age of 18.

- Patients who have received prior therapy with any anti-VEGF drug, including

- Patients with human immunodeficiency virus (HIV).

- Patients with medical history or conditions not otherwise previously specified which
in the opinion of the investigator should exclude participation in this study. The
investigator should consult the Study Chair.

Type of Study:


Study Design:

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

Outcome Measure:

Event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)

Outcome Description:

Any of the following occurrences will be considered an event: Delay of day 1 of therapy > 3 weeks from the expected day 1 of that cycle Febrile neutropenia requiring hospitalization Grade 4 thrombocytopenia Grade 1-5 gastrointestinal perforation Grade 3-4 hemorrhagic toxicity Grade 3-4 arterial thromboembolic complications Grade 4 hypertension Grade 4 proteinuria Fascial dehiscence or any event requiring reoperation in chemotherapy cycles after surgery The regimen would be considered unfeasible for further study if an event occurs in at least 25% of patients.

Outcome Time Frame:

Up to 30 days after the last treatment

Safety Issue:


Principal Investigator

Jason D Wright, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

May 2015

Related Keywords:

  • Epithelial Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of VirginiaCharlottesville, Virginia  22908
Yale UniversityNew Haven, Connecticut  06520
Columbia University Medical CenterNew York, New York  10032