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Pilot Study of Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies

18 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Pilot Study of Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies

- Each treatment cycle lasts three weeks and participants will be seen and examined by
their medical team every three weeks.

- Avastin will be given at the standard dose every three weeks intravenously. After two
treatments of Avastin, participants will undergo a repeat CT or MRI scan and a check of
their CA125 blood level to determine how the Avastin is affecting their disease. If
their cancer is not growing or shrinking and the participant is not having significant
side effects, the Avastin will continue for another two cycles.

- If however, it is discovered that the participant's cancer is growing and they are not
experiencing any bad symptoms, then they will start cyclophosphamide orally.
Cyclophosphamide is taken at home by mouth every day. The participant's cancer will be
rechecked in six weeks, and if the cancer is not growing or is shrinking and the
participant is not experiencing any significant side effects, they will continue on the
combination therapy.

Inclusion Criteria:

- Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal
cancer, or fallopian tube cancer.

- Recurrent cancer and have received and failed a previous platinum-based chemotherapy

- Up to 2 prior lines of chemotherapy in the recurrent setting (either platinum-based
or non-platinum regimens). Biologic therapies count as a prior line but hormonal
therapies do not count.

- Platinum-resistant or platinum-sensitive recurrence.

- Must be able to take oral medications and have no evidence of bowel obstruction or
partial bowel obstruction

- Measurable disease by either RECIST or Rustin criteria

- No chemotherapy, radiation therapy, nor biologic therapy within the last three weeks
prior to initiating therapy

- ECOG score of 0 or 1

- Life expectancy of 12 weeks or greater

- 18 years of age or older

- Laboratory values as outlined in the protocol

- Patients with treated limited stage basal cell or squamous cell carcinoma of the skin
or carcinoma in situ of the breast or cervix are eligible. Subjects with stage I or
II cancer treated with curative intent and no evidence of recurrent disease are also

- No evidence of preexisting hypertension. If patient has hypertension, it must be
controlled medically (less than 150/90) prior to starting bevacizumab

- Normal blood coagulation parameters

- No prior treatment with any other antiangiogenic agents or cyclophosphamide

- For patients who have received prior doxorubicin or pegylated doxorubicin, LVEF must
be 50% or greater.

Exclusion Criteria:

- Current, recent (within 4 weeks of the first study infusion), or planned
participation in an experimental drug study other than a Genentech-sponsored
bevacizumab cancer study

- Active malignancy, other than superficial basal cell and superficial squamous (skin)
cell, or carcinoma in situ of the cervix within last five years

- Uncontrolled diarrhea

- Prior history of hypertensive crisis or hypertensive encephalopathy

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to Day 1

- History of stroke or transient ischemic attack within 6 months prior to day 1

- Known CNS disease, except for treated brain metastasis

- 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.

- Significant vascular disease within 6 months prior to day 1

- History of hemoptysis within 1 month prior to day 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to day 1 or anticipation of need for major surgical procedure during the course
of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Proteinuria as demonstrated by a UPC ratio of 1.0 or greater at screening

- Known hypersensitivity to any component of bevacizumab

- Pregnancy (positive pregnancy test) or lactation. Use of effective means of
contraception (men and women) in subjects of child-bearing potential

Type of Study:


Study Design:

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

Outcome Measure:

Assess the safety profile of this study regimen with respect to gastrointestinal perforations using a two-stage design.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ursula Matulonis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • avastin
  • bevacizumab
  • cyclophosphamide
  • cytoxan
  • mullerian malignancies
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617