Clinical trial NCT00436501 (phase 1/phase 2, status: completed)
Conditions: fallopian tube cancer, malignant tumor of peritoneum, recurrent ovarian epithelial cancer
ICD codes: C57.00, C57.01, C57.02, C48.2, C48.1, C78.6, C48.8, H18.523, H18.521, H18.522, H18.529
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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) < 2.5 times upper
             limit of normal (ULN)

          -  Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min

          -  Prothrombin Time (PT)/international normalized ratio (INR) < 1.5 OR in-range INR 2-3
             (if patient is on a stable dose of therapeutic warfarin or low molecular weight
             heparin)

          -  PTT < 1.2 times control

          -  Urine protein:creatinine ratio < 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 6 months
             after completion of study treatment

          -  No active infection requiring antibiotics

          -  No sensory and motor neuropathy >= 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 OR 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 =< 1:

        Alopecia allowed

          -  No prior VEGF Trap

          -  No prior cancer treatment that would preclude study treatment

          -  Prior paclitaxel allowed

          -  Prior docetaxel for primary or recurrent disease allowed provided the following
             criteria are met:

        No disease progression during therapy; No disease relapse within 3 months of completing
        therapy; No persistent disease at the completion of primary therapy

          -  More than 7 days since prior placement of a vascular access device or core biopsy

          -  At least 1 week since prior hormonal therapy for the malignant tumor

          -  At least 4 weeks since other prior therapy, including immunologic agents (6 weeks for
             nitrosoureas or mitomycin C)

          -  More than 28 days since prior major surgery, open biopsy, dental extraction, or other
             dental surgery/procedure resulting in an open wound

          -  No concurrent major surgery

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents

          -  No concurrent hematopoietic growth factors during course 1 of phase I

          -  Concurrent hormone replacement therapy allowed

          -  White blood count (WBC) >= 3,000/mm^3