Clinical trial NCT02244502 (phase 1/phase 2, status: unknown status)
Conditions: ovarian carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: paclitaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma
             or primary peritoneal carcinoma

          2. Recurrent ovarian cancer with any number of prior therapies

          3. 18 years of age and older

          4. Life expectancy of at least 12 weeks

          5. Measurable disease according to the revised RECIST criteria version 1.1. A lesion in a
             previously irradiated field is considered "non-measurable" and cannot be a "target
             lesion".

          6. ECOG score 0-1 (see Appendix A)

          7. Adequate bone marrow, liver and renal functions:

               1. Absolute neutrophil count ≥ 1.5 x 10 9/L

               2. Platelet count ≥ 100 x 10 9/L

               3. Hemoglobin ≥ 10 g/dL

               4. AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient
                  has documented liver metastases

               5. Bilirubin ≤1.5 x ULN

               6. Serum creatinine ≤ 1.5 x ULN

               7. Coagulation status: PT and PTT within normal limits or within therapeutic limits
                  for patients receiving anticoagulation.

          8. Able to operate the NovoTTF-100L(O) System independently or with the help of a
             caregiver

          9. No concurrent anti-tumor therapy (beyond weekly paclitaxel and NovoTTF Therapy as per
             protocol)

         10. At least 4 weeks since major surgery

        Exclusion Criteria:

          1. Meningeal carcinomatosis or known brain metastases which have not been treated,
             require steroid treatment, or are symptomatic.

          2. Any other malignancy requiring anti-tumor treatment in the past three years, except
             resected non-melanomatous skin cancer, breast carcinoma in situ, adequately treated
             stage I breast cancer or in situ cervical cancer.

          3. Chemotherapy within 4 weeks prior to treatment start.

          4. Radiotherapy within 4 weeks prior to treatment start.

          5. Significant comorbidity which is expected to affect patient's prognosis or ability to
             receive the combined therapy:

               1. History of significant cardiovascular disease unless the disease is well
                  controlled. Significant cardiac disease includes second/third degree heart block;
                  significant ischemic heart disease; poorly controlled hypertension; congestive
                  heart failure of the New York Heart Association (NYHA) Class II or worse (slight
                  limitation of physical activity; comfortable at rest, but ordinary activity
                  results in fatigue, palpitation or dyspnea).

               2. History of arrhythmia that is symptomatic or requires treatment. Patients with
                  stable atrial fibrillation or flutter controlled by medication are not excluded
                  from participation in the trial.

               3. Active infection or any serious underlying medical condition that would impair
                  the ability of the patient to receive protocol therapy.

               4. History of any psychiatric condition that might impair the patient's ability to
                  understand or comply with the requirements of the study or to provide consent.

          6. Implantable electronic medical devices including pacemaker, implantable automatic
             defibrillator, etc.

          7. Known history of sensitivity to taxanes or drugs containing Cremophor

          8. Grade 2 or greater peripheral neuropathy

          9. Known allergies to medical adhesives or hydrogel

         10. Pregnant or breast feeding