Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity (WAR)
Primary Purpose
Recurrent Ovarian Carcinoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Whole Abdomen Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Ovarian Carcinoma focused on measuring Recurrent Ovarian Carcinoma, Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Huntsman Cancer Institute
Outcomes
Primary Outcome Measures
Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity
Secondary Outcome Measures
Quality of Life assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00942838
Brief Title
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity
Acronym
WAR
Official Title
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity: A Phase I Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
PI decision due to under accrual.
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 whole abdomen radiation. The primary end point of this investigator initiated research study is to determine the toxicity associated with whole abdomen radiation in combination with intraperitoneal chemotherapy.
Primary Objective:
Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity.
Secondary Objective:
Quality of Life assessment.
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 for 3 months. We would like to collect information from the patients regular doctor for 1 year after this treatment.
Pre-screening If patients decide to participate in this study the doctor will evaluate if they have met all the criteria to be eligible. To participate the cancer cannot have spread outside the abdomen and patients must have had only one type of chemotherapy for their cancer. If there any of their previous scans or blood tests show that the cancer has spread outside the abdominal cavity, patients will not be able to participate in this study. Patients will also not be able to participate in this study if it is determined that their cancer has come back less than six months after they completed their first treatment of chemotherapy. If these criteria are met, the standard next step for treatment is to have a second surgery to remove all or most of the cancer from the abdominal cavity. This will involve a similar surgery to what patients had when their cancer was first diagnosed. During this surgery we will place a special catheter or tube within the abdominal cavity so that we can administer chemotherapy into the abdomen directly and deliver it to the remaining cancer.
Screening Procedures:
The following screening tests, exams and procedures will be done:
Recording of medical history, physical exam (including vital signs, height & weight assessment, pelvic examination)
Blood tests (approximately 2-3 teaspoons will be drawn)
Urine tests
Quality of life questionnaire
If patients have a history of hearing loss, they will have a hearing test because cisplatin can affect hearing.
Chemotherapy and Radiation Treatment:
Chemotherapy (Cisplatin) will be given to after recovery from surgery. It will be given once per week at the same time as patients begin receiving the radiation treatment for the first 4 weeks. The chemotherapy will be given through the catheter (tube) that was placed under the skin during surgery and will not be visible. Patients will receive medication prior to the chemotherapy to prevent nausea, vomiting, and possible allergic reaction. Each infusion of chemotherapy will take approximately 60 minutes. After patients receive the drug we will ask to change positions to ensure that the drug comes in contact with all parts of the abdomen.
Radiation therapy will be administered for four weeks. Radiation treatments will be given every day (Monday through Friday) for approximately four weeks.
Weekly blood tests will be taken before patients receive the chemotherapy (approximately 2-3 teaspoons) to monitor the effects of the drug on the body.
The study doctor will evaluate patients weekly with a physical exam and review their blood tests for any side effects they might be having from the chemotherapy or radiation treatments.
Complete a quality of life questionnaire each week.
At the end of treatment (beginning of week 5) AND approximately 90 days after the completion of treatment patients will have a physical exam, blood tests evaluation of the side effects, and will complete a quality of life questionnaire.
At the end of treatment, patients will likely undergo additional standard chemotherapy treatment. We would like to collect and review the information about their progress and care for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Carcinoma
Keywords
Recurrent Ovarian Carcinoma, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatin, PLATINOL®-AQ
Intervention Description
PLATINOL®-AQ (cisplatin injection) is a clear, colorless, sterile aqueous solution, each mL containing 1 mg cisplatin and 9 mg Sodium Chloride, USP. HCl and/or Sodium Hydroxide is added to adjust pH of the solution. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C.
Intervention Type
Radiation
Intervention Name(s)
Whole Abdomen Radiotherapy
Other Intervention Name(s)
radiation therapy
Intervention Description
Whole abdominal radiotherapy will be delivered with an open-field anterior-posterior/posterior-anterior technique. Radiation will be administered in a dose escalating fashion to determine toxicity. The maximal dose of radiation will be defined as a mean midplane dose to the abdomen of 3,000 Gy through parallel-opposed single ports with a 1-cm margin that will cover the entire abdomen including the diaphragm.
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity
Time Frame
2 years after study start
Secondary Outcome Measure Information:
Title
Quality of Life assessment
Time Frame
2 years after study start
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew P. Soisson
Organizational Affiliation
Huntsman Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity
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