Recurrent Ovarian CarcinomaPhase 1WARNCT00942838
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity
A Phase 1 study testing Cisplatin and Whole Abdomen Radiotherapy in people with Recurrent Ovarian Carcinoma, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Carcinoma
- What is being tested?
- Cisplatin and Whole Abdomen Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Recurrent Ovarian Carcinoma
- Being tested
- Cisplatin, Whole Abdomen Radiotherapy
- Keywords
- Recurrent Ovarian Carcinoma, Cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Cisplatin, PLATINOL®-AQ
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.
Whole Abdomen RadiotherapyRadiation
Also called radiation therapy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after study start
Secondary outcomes (1)
Quality of Life assessment
Measured: 2 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: PI decision due to under accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew P. Soisson, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942838
- Sponsor's protocol ID
- HCI28777
- Acronym
- WAR
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00942838
- Acronym / sponsor ID
- WAR / HCI28777
- Conditions
- Recurrent Ovarian Carcinoma
- Keywords
- Recurrent Ovarian Carcinoma, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision due to under accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: Cisplatin, PLATINOL®-AQPLATINOL®-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. | Drug | – |
| Whole Abdomen RadiotherapyAlso: radiation therapyWhole 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. | Radiation | – |
Primary outcome
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
1 secondary outcome
Quality of Life assessment
Time frame: 2 years after study start
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew P. Soisson principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin and Whole Abdomen Radiotherapy in people with Recurrent Ovarian Carcinoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.