Phase
Condition
Carcinoma
Ovarian Cysts
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Recurrent ovarian cancer or primary peritoneal cancer with disease confined to theabdomen and pelvis, who have undergone optimal cytoreductive surgery for recurrence
Must have received only one prior chemotherapeutic regimen as their prior therapy
Eligible patients must have received platinum based intravenous chemotherapy as theironly prior therapy. Previous treatment with maintenance chemotherapy after initialadjuvant chemotherapy is acceptable, including anti-estrogen therapy and growthfactors. Previous intraperitoneal chemotherapy is not allowed
Patients have evidence of recurrent cancer manifested by either a) elevation in serumCA-125 or a palpable tumor on physical exam and/or b) radiographic evidence ofrecurrence. (Note that a tissue biopsy for histologic confirmation of tumor recurrenceprior to cytoreductive surgery is not necessary, however histologic confirmation ofthe removed tumor is necessary- see exclusion 5.22)
Tumors with serous, mucinous, clear cell, or endometrioid histologic types areeligible
Recurrent disease must be confined to the abdominal cavity
Recurrence of tumor must be greater than six months from completion of primarychemotherapy (platinum sensitive ovarian cancer)
Patients have undergone a second cytoreductive surgery to remove all gross residualdisease. This cytoreductive surgery must occur within twelve weeks of enrollment
Patients have or are planning to have an IP catheter
Patients who require rectosigmoid resection with primary anastamosis will be eligible
Adequate renal function as defined by serum creatinine less 2.0mg/dL
Patients must have appropriate hematologic parameters with total white blood cell (WBC) counts ≥ 3,000cells/mcl and platelet counts ≥ 100,000/mcl prior to treatmentinitiation
Patients must have the absence of pleural effusions on chest radiographs
Patients must sign informed consent approved by the University of Utah andinstitutional review board (IRB)
ECOG performance status less than or equal to 2
Age greater than 18 years old
Exclusion
Exclusion Criteria:
Patients previously characterized with stage IV disease or those with stage IIIC whounderwent suboptimal secondary cytoreductive surgery for recurrence will not beeligible for participation
Patients who undergo secondary cytoreductive surgery for recurrence and have norecurrent disease by histologic documentation will not be eligible
Those with preoperative evaluation consistent with stage IV disease (pleural effusionor liver parenchymal disease)
Patients with disease outside the peritoneal cavity including disease in the thorax,within the parenchyma of the liver, spleen, or retroperitoneal nodal disease will notbe eligible for participation
Patients with other invasive malignancies, with the exception of non-melanoma skincancer, who had (or have) any evidence of the other cancer present within the last 5years or whose previous cancer treatment contraindicates this protocol therapy
Patients determined to have platinum resistant ovarian or primary peritoneal cancer
Those who had suboptimal cytoreductive surgery at the time of first diagnosis. Thisincludes patients who had a suboptimal cytoreductive surgery followed by chemotherapy,then a secondary debulking and now have a recurrence
Those with > 1cm residual disease after the second cytoreductive surgery
Patients that have been treated with previous intraperitoneal chemotherapy
Patients that are pregnant or lactating
Patients with peripheral neuropathy greater than grade 2 at baseline
Study Design
Study Description
Connect with a study center
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available

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