Clinical trial NCT00942838 (phase 1, status: withdrawn)
Conditions: recurrent ovarian carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: cisplatin
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
Reason stopped: 
    pi decision due to under accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Recurrent ovarian cancer or primary peritoneal cancer with disease confined to the
             abdomen and pelvis, who have undergone optimal cytoreductive surgery for recurrence

          2. Must have received only one prior chemotherapeutic regimen as their prior therapy

          3. Eligible patients must have received platinum based intravenous chemotherapy as their
             only prior therapy. Previous treatment with maintenance chemotherapy after initial
             adjuvant chemotherapy is acceptable, including anti-estrogen therapy and growth
             factors. Previous intraperitoneal chemotherapy is not allowed

          4. Patients have evidence of recurrent cancer manifested by either a) elevation in serum
             CA-125 or a palpable tumor on physical exam and/or b) radiographic evidence of
             recurrence. (Note that a tissue biopsy for histologic confirmation of tumor recurrence
             prior to cytoreductive surgery is not necessary, however histologic confirmation of
             the removed tumor is necessary- see exclusion 5.22)

          5. Tumors with serous, mucinous, clear cell, or endometrioid histologic types are
             eligible

          6. Recurrent disease must be confined to the abdominal cavity

          7. Recurrence of tumor must be greater than six months from completion of primary
             chemotherapy (platinum sensitive ovarian cancer)

          8. Patients have undergone a second cytoreductive surgery to remove all gross residual
             disease. This cytoreductive surgery must occur within twelve weeks of enrollment

          9. Patients have or are planning to have an IP catheter

         10. Patients who require rectosigmoid resection with primary anastamosis will be eligible

         11. Adequate renal function as defined by serum creatinine less 2.0mg/dL

         12. Patients must have appropriate hematologic parameters with total white blood cell
             (WBC) counts ≥ 3,000cells/mcl and platelet counts ≥ 100,000/mcl prior to treatment
             initiation

         13. Patients must have the absence of pleural effusions on chest radiographs

         14. Patients must sign informed consent approved by the University of Utah and
             institutional review board (IRB)

         15. ECOG performance status less than or equal to 2

         16. Age greater than 18 years old

        Exclusion Criteria:

          1. Patients previously characterized with stage IV disease or those with stage IIIC who
             underwent suboptimal secondary cytoreductive surgery for recurrence will not be
             eligible for participation

          2. Patients who undergo secondary cytoreductive surgery for recurrence and have no
             recurrent disease by histologic documentation will not be eligible

          3. Those with preoperative evaluation consistent with stage IV disease (pleural effusion
             or liver parenchymal disease)

          4. Patients with disease outside the peritoneal cavity including disease in the thorax,
             within the parenchyma of the liver, spleen, or retroperitoneal nodal disease will not
             be eligible for participation

          5. Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer, who had (or have) any evidence of the other cancer present within the last 5
             years or whose previous cancer treatment contraindicates this protocol therapy

          6. Patients determined to have platinum resistant ovarian or primary peritoneal cancer

          7. Those who had suboptimal cytoreductive surgery at the time of first diagnosis. This
             includes patients who had a suboptimal cytoreductive surgery followed by chemotherapy,
             then a secondary debulking and now have a recurrence

          8. Those with > 1cm residual disease after the second cytoreductive surgery

          9. Patients that have been treated with previous intraperitoneal chemotherapy

         10. Patients that are pregnant or lactating

         11. Patients with peripheral neuropathy greater than grade 2 at baseline