VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Fallopian Tube Cancer · Malignant Tumor of Peritoneum · Recurrent Ovarian Epithelial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00436501 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); ziv-aflibercept (Biological); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of VEGF Trap (Phase I) |
6 | — |
| PRIMARY Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 11; 2; 14 | — |
| PRIMARY Median Overall Survival (OS) (Phase II) |
26.6 | — |
| PRIMARY Overall Objective Response Rate According to RECIST (Phase II) |
54 | — |
| PRIMARY Median Progression-Free Survival (PFS) (Phase II) |
6.4 | — |
| SECONDARY Overall Median Duration of Response (Phase II) |
6.0 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Effects as Assessed by NCI CTCAE v3.0 (Phase II) |
9; 46 | — |
| SECONDARY Number of Participants With PFS (Phase II) |
2; 11; 3; 10; 4; 14 | — |
Summary
Eligibility Criteria
Criteria:
- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer:
Persistent or recurrent disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques:
- Must have >= 1 target lesion to assess response;
- Tumors within a previously irradiated field are considered nontarget lesions
- Must have received 1 prior platinum-based chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound:
Initial treatment may have included any of the following:
- High-dose therapy;
- Consolidation therapy;
- Extended therapy administered after surgical or nonsurgical assessment
- AND Must have received 1 prior platinum-based chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound:
One additional cytotoxic regimen for recurrent or persistent disease allowed
- No history or evidence of CNS disease, including primary brain tumor or brain metastases
- Zubrod performance status 0-2 (0-1 for patients who received 2 prior regimens [taxane and/or platinum regimens are counted separately])
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- Bilirubin normal
- aspartate aminotransferase / alanine aminotransferase (AST/ALT) 60 mL/min
- Prothrombin Time (PT)/international normalized ratio (INR) = grade 2
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to VEGF Trap, Magnevist, or fludeoxyglucose F 18
- No history of allergic reaction to paclitaxel or docetaxel or to products mixed in Cremophor EL or Tween 80
- No active bleeding or pathologic condition that would carry a high risk of bleeding, including any of the following:
Known bleeding disorder; Coagulopathy; Peptic ulcer disease; Diverticulitis; Tumor involving major vessels
- No active and/or untreated pulmonary embolism, deep vein thrombosis, or other thromboembolic event (i.e., any condition associated with aberrant clotting or migration of an induced clot)
- No history or evidence of other CNS disease, including any of the following:
Seizures not controlled with standard medical therapy; Cerebrovascular accident; Transient ischemic attack; Subarachnoid hemorrhage within the past 6 months
- No clinically significant cardiovascular disease, including any of the following:
Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg; systolic BP > 180 mm Hg and diastolic BP 90 mm Hg on >= 2 measurements within the past 3 months); Myocardial infarction; Coronary or peripheral artery bypass graft
- No clinically significant cardiovascular disease, including any of the following:
New York Heart association class III or IV congestive heart failure; Serious cardiac arrhythmia requiring medication; Peripheral vascular disease >= grade 2; Unstable angina within the past 6 months; Clinically significant peripheral artery disease (e.g., claudication) within the past 6 months
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Able to undergo an MRI scan:
No claustrophobia; No implanted devices or metallic foreign bodies not compatible with MRI (e.g., ferromagnetic implants or pacemakers); No known history of allergic reaction to gadolinium contrast agents
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No significant traumatic injury within the past 28 days
- Recovered from prior therapy to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = = 3,000/mm^3
Data sourced from ClinicalTrials.gov (NCT00436501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.