Clinical trial NCT01083537 (phase 1/phase 2, status: terminated)
Conditions: ovarian cancer, peritoneal cancer, fallopian tube cancer, bowel obstruction
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02, C57.00, C57.01, C57.02, K22.2, K31.5, K82.0, N32.0, K56.609, K56.699, J04.10
Drugs: cisplatin, paclitaxel
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [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
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Hospital admission and diagnosis compatible with Malignant Bowel Obstruction, as
             defined below:

               1. A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian
                  tube cancer

               2. At least two of the following four symptoms: (a) vomiting (>2 episodes in past 24
                  hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d)
                  severe constipation (no bowel movement >24 hours).

               3. CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms
                  diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in
                  determining the location and etiology of obstruction.

          -  Non-surgical candidate

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Patients must be 18 years of age or older.

          -  ECOG performance status 0, 1 or 2 (Karnofsky > or = 60%) one week prior to admission.

          -  Patients must have adequate hematological function as defined below:

          -  Absolute granulocyte count > or = 1.5 x 10^9/L

          -  Platelet count > or = 100 x 10^9/L

          -  Patients must have adequate renal and hepatic function as defined below:

          -  Serum creatinine < or = 1.5 x ULN OR a calculated creatinine clearance > or = 50
             ml/min

          -  Bilirubin < or = 3 x ULN, AST < or = 5 x ULN, ALT < or = 5 x ULN

        Exclusion Criteria:

          -  Patients diagnosed with MBO caused by malignancy other than primary ovarian cancer.

          -  Patients diagnosed with MBO who are surgical candidates.

          -  Patients who are pregnant or breast-feeding.

          -  Concomitant diagnosis of GI malignancy (platinum ineffective) within past 5 years.

          -  History of severe hypersensitivity reaction to Cisplatin and Paclitaxel.

          -  Patients who have received chemotherapy within 2 weeks prior to study enrollment.

          -  Patients with uncontrolled Inflammatory Bowel Disease.

          -  Patients with concurrent active infections with Clostridium Difficile.

          -  Early postoperative obstruction (within 30 days from previous operation).

          -  Patients who have had bowel irradiation within 6 weeks.

          -  Patients with any of the following conditions are excluded:

          -  Myocardial infarction within 6 months prior to entry.

          -  Congestive heart failure.

          -  Unstable angina.

          -  Active cardiomyopathy.

          -  Unstable ventricular arrhythmia.

          -  Uncontrolled hypertension.

          -  Uncontrolled psychotic disorders.

          -  Serious infections.

          -  Active peptic ulcer disease.

          -  Uncontrolled psychiatric illness.

          -  Any other medical conditions that might be aggravated by treatment or limit
             compliance.