Status:
WITHDRAWN
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity
Lead Sponsor:
University of Utah
Conditions:
Recurrent Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The proposed study is a prospective cohort study incorporating patients with first recurrence ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in conjunction with who...
Detailed Description
DESIGN: This is an open label, single arm, dose finding study. STUDY PROCEDURES: Patients will receive chemotherapy and radiation for four weeks, and we will check for any problems from the treatment...
Eligibility Criteria
Inclusion
- Recurrent ovarian cancer or primary peritoneal cancer with disease confined to the abdomen 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 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
- 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)
- Tumors with serous, mucinous, clear cell, or endometrioid histologic types are eligible
- Recurrent disease must be confined to the abdominal cavity
- Recurrence of tumor must be greater than six months from completion of primary chemotherapy (platinum sensitive ovarian cancer)
- Patients have undergone a second cytoreductive surgery to remove all gross residual disease. 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 treatment initiation
- Patients must have the absence of pleural effusions on chest radiographs
- Patients must sign informed consent approved by the University of Utah and institutional review board (IRB)
- ECOG performance status less than or equal to 2
- Age greater than 18 years old
Exclusion
- 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
- Patients who undergo secondary cytoreductive surgery for recurrence and have no recurrent disease by histologic documentation will not be eligible
- Those with preoperative evaluation consistent with stage IV disease (pleural effusion or 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 not be eligible for participation
- 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
- Patients determined to have platinum resistant ovarian or primary peritoneal cancer
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00942838
Start Date
July 1 2009
End Date
April 1 2010
Last Update
July 24 2013
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112