Overview

This trial is active, not recruiting.

Conditions ovarian cancer, peritoneal cancer, fallopian tube cancer
Treatments avastin, cyclophosphamide
Target VEGF
Sponsor Dana-Farber Cancer Institute
Collaborator Massachusetts General Hospital
Start date February 2009
End date September 2013
Trial size 20 participants
Trial identifier NCT00856180, 08-148

Summary

The purpose of this study is to see if it is safe to give Avastin (bevacizumab) and Cyclophosphamide (cytoxan) together without causing serious side effects. Both of these drugs are given in an attempt to block new blood vessel growth to the cancer. The participants cancer will be monitored every six weeks with a Computerized Axial Tomography scan (CT) or Magnetic Resonance Imaging (MRI) scan and/or with a blood test, CA125. The first drug used will be Avastin. If the participants cancer does not grow or shrinks, then they will be kept on this drug alone. If the participants cancer grows and/or their CA125 blood test rises during the Avastin treatment, then we will add Cyclophosphamide.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous Avastin Alone
avastin bevacizumab
Standard dose given intravenously every three weeks
(Experimental)
Avastin plus cyclophosphamide
avastin bevacizumab
Standard dose given intravenously every three weeks
cyclophosphamide cytoxan
Taken orally once a day

Primary Outcomes

Measure
Assess the safety profile of this study regimen with respect to gastrointestinal perforations using a two-stage design.
time frame: 2 years
Assess proportion of patients who remain on study at three months (4 cycles of treatment).
time frame: 2 years

Secondary Outcomes

Measure
Assess other toxicity and safety profile of this metronomic antiangiogenic approach.
time frame: 2 years
Assess preliminary response rate and proportion of patients on study at 6 months.
time frame: 2 years
Assess progression-free survival
time frame: 3 years
Assess time to progression and overall survival
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 regimen. - 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 eligible. - 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

Additional Information

Official title Pilot Study of Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies
Principal investigator Ursula Matulonis, MD
Description - 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.