Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma
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
3 other identifiers
interventional
45
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
October 11, 2013
CompletedFebruary 6, 2014
May 1, 2013
5.6 years
July 17, 2007
May 28, 2013
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six Month Progression Free Survival (PFS)
Percentage of participants with PFS at six months. PFS: 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.
6 months per participant
Secondary Outcomes (4)
Median Progression Free Survival
Up to 5 years
Overall Response Rate (RR)
Up to 5 years
Occurrence of Grade 3 or 4 Toxicity
Up to 4 years
Overall Survival (OS)
Up to 5 years
Study Arms (1)
Avastin and Docetaxel
EXPERIMENTALCombination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Interventions
Eligibility Criteria
You may qualify if:
- 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 \</= 2
- 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 \</= upper limit of normal (ULN), alanine transaminase (AST) 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 treatment.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- National Cancer Institute (NCI)collaborator
- Genentech, Inc.collaborator
- Sanoficollaborator
Study Sites (4)
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, 33316, United States
Women's Cancer Associates
St. Petersburg, Florida, 33701, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Wenham, Principal Investigator
- Organization
- H. Lee Moffitt Cancer Center and Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M. Wenham, MD
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 19, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 6, 2014
Results First Posted
October 11, 2013
Record last verified: 2013-05