Ovarian Cancer Clinical Trial

Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

Summary

The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.

View Eligibility Criteria

Eligibility Criteria

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 cancer antigen (CA)125 criteria [Journal of the National Cancer Institute (JNCI), 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 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 treatment.

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 carcinomas
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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00504257

Recruitment Status:

Completed

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There are 4 Locations for this study

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Broward General Medical Center Cancer Center
Fort Lauderdale Florida, 33316, United States
Women's Cancer Associates
Saint Petersburg Florida, 33701, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Duke Cancer Institute
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00504257

Recruitment Status:

Completed

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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