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Phase 2 N=58 Treatment

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

Enrolled (actual)
58
Serious AEs
92.7%
Results posted
Mar 2015
Primary outcome: Primary: Maximum Tolerated Dose of VEGF Trap (Phase I) — 6 mg/kg

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

OutcomeResultp-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

This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with docetaxel may kill more tumor cells

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
View full record on ClinicalTrials.gov →

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.

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