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A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Malignant Tumor of Peritoneum

Thank you

Trial Information

A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

Inclusion Criteria:

- Signed informed consent

- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or
fallopian tube cancer

- Patient's disease recurrence or progression occurs between 0 to 12 months (1 to 365
days) from prior platinum-containing chemotherapy regimen. Patients, however, may not
receive study drug until at least 28 days from prior chemotherapy.

- The patient may have received up to three prior chemotherapy regimens for the
treatment of this malignancy. Patients who may have received prior treatment with
paclitaxel and/or a platinum compound will be allowed. Rechallenge with the same
platinum based regimen is considered 1 prior regimen. Patients who have been treated
with consolidation treatment are allowed and the consolidation will not be considered
a separate regimen. Hormonal therapy (i.e. progesterones, estrogens, anti-estrogens,
aromatase inhibitors) will not be considered a prior chemotherapy regimen.

- Measurable or evaluable disease either by the Gynecologic Oncology Group (GOG)
Response Evaluation Criteria in Solid Tumors (RECIST) or CA 125 criteria (Journal of
the National Cancer Institute, Vol. 96, No. 6, March 17, 2004, Vergote JNCI 2000)

- At least 4 weeks since major surgery, with full recovery

- At least 3 weeks since radiotherapy, with full recovery. The measurable disease must
be completely outside of the radiation port.

- Eastern Cooperative Oncology Group (ECOG) performance status
- Hematologic (minimal values): Absolute neutrophil count >/= 1,500/mm^3, Hemoglobin
>/= 8.0 g/dL (transfusions allowed), Platelet count >/= 100,000/mm^3

- Hepatic: Total Bilirubin and alanine transaminase (ALT) and alkaline phosphatase must be within the range
allowing for eligibility. In determining eligibility the more abnormal of the 2
values (AST or ALT) should be used.

- Women of childbearing potential must have a negative pregnancy test.

- Patients of childbearing potential must be willing to consent to using effective
contraception while on treatment and for 3 months following the completion of

Exclusion Criteria:

Prior treatment with Docetaxel or Avastin

- Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment
for the ovarian cancer. Any hormonal therapy directed at the malignant tumor must be
discontinued at least one week prior to enrollment in order for the patient to be
eligible to participate in this trial. Continuation of hormonal replacement therapy
is allowed.

- Peripheral neuropathy >/= grade 2

- History of a severe hypersensitivity reaction to Docetaxel, Avastin, or to other
drugs formulated with polysorbate (Tween) 80.

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study of Avastin

- Blood pressure of >150/100 mmHg Unstable angina

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

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

- History of stroke within 6 months prior to Day 1

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Presence of central nervous system or brain metastases

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0

- Pregnant (positive pregnancy test) or lactating

- Urine protein: creatinine ratio >/= 1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

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

- Evidence of malignancy in the last 5 years, other than nonmelanoma cutaneous

- History of hemoptysis (bright red blood of 1/2 teaspoon or more) within last 3 months

- Patients believed to possibly be at higher than average risk of perforation will be
excluded from study. This includes symptoms or findings of partial or complete bowel
obstruction, history of fistula, patients requiring parenteral nutrition and
hydration, and those with history of prior perforation due to tumor or perforation
within last 6 months from other causes.

- Inability to comply with study and/or follow-up procedures.

- Patients who are not on a stable dose of anticoagulation therapy. Patients who are on
a stable anticoagulation regimen, including coumadin or low molecular-weight heparin,
will not be excluded.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival (PFS) at 6 Months

Outcome Description:

Progression-Free Survival (PFS): is the period from study entry until disease progression, death due to disease progression or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.

Outcome Time Frame:

6 months per participant

Safety Issue:


Principal Investigator

Robert M. Wenham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

March 2007

Completion Date:

October 2012

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Malignant Tumor of Peritoneum
  • recurrent ovarian epithelial cancer
  • recurrent primary peritoneal cavity cancer
  • recurrent fallopian tube cancer
  • Neoplasms
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Duke Cancer InstituteDurham, North Carolina  27710
Women's Cancer AssociatesSaint Petersburg, Florida  33701