Ovarian CancerNCT01144442
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
A study testing Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate) and Surgery in people with Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 16 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate) and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2010to 1 May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
- Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
- End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
- Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
- Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
- Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
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- Patients must have a performance status of 0, 1, 2.
- Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an Institutional Review Board (IRB) approved informed consent.
- Female patients 16-90 years of age.
- Patients must be deemed medically able to undergo a secondary surgical procedure.
- Patient eligibility for systemic chemotherapy following HIPC:
- Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.
- Patients must have a performance status of 0, 1, or 2.
- Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an IRB approved informed consent.
Who cannot join
- Patients with known recurrent disease outside the abdominal cavity.
- Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
- Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
- Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
- Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
- Patients with history of grade 3 or greater gastrointestinal bleeding.
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- Patients with a GOG performance score of 3 or 4.
- Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
- Patients with known allergy to platinum chemotherapy agents.
- Patients with equal to or greater than grade 2 neuropathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.
Read the detailed description
OBJECTIVES
- The primary objectives are
- to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
- to determine the feasibility of delivering HIPC in a recurrent setting.
- Secondary objectives are
- to determine disease free survival (DFS) and overall survival (OS),
- to determine treatment related changes in quality of life (QOL)
- to monitor the toxicities and complications associated with HIPC.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Being tested
- Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate), Surgery, Carboplatin, Paclitaxel
- Keywords
- recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent peritoneal carcinoma
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapy with CarboplatinDrug
Carboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.
Isotonic saline (perfusate)Other
Also called saline
The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
SurgeryProcedure or surgery
The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus.
If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.
CarboplatinDrug
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
PaclitaxelDrug
Also called Taxol
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
| Study group | Role | What they receive |
|---|---|---|
| HIPC Treatment | Experimental | Not described Receives: Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin; Other: Isotonic saline (perfusate); Procedure: Surgery; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
Measured: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
Feasibility of HIPC in Recurrent Disease Setting
We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
Measured: 6 months
Secondary outcomes (3)
Quality of Life Measurements
The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.
Measured: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Progression-free Survival
Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).
Measured: Up to 5 Years (intended)
Overall Survival
Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study start27 Jul 2010
- Primary completion25 Sep 2013
- Study completion1 May 2015
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Argenta, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144442
- Sponsor's protocol ID
- 2009LS114
- Other IDs
- WCC# 59, 1003M78874
- Status last verified
- Jul 2019
- First submitted
- 26 May 2010
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
- ClinicalTrials.gov ID
- NCT01144442
- Acronym / sponsor ID
- 2009LS114
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Keywords
- recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent peritoneal carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Request
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 27 Jul 2010 (actual)
- Primary completion
- 25 Sep 2013 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 5 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.
Detailed description
OBJECTIVES
- The primary objectives are
- to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
- to determine the feasibility of delivering HIPC in a recurrent setting.
- Secondary objectives are
- to determine disease free survival (DFS) and overall survival (OS),
- to determine treatment related changes in quality of life (QOL)
- to monitor the toxicities and complications associated with HIPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPC Treatment | Experimental | Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin, Other: Isotonic saline (perfusate), Procedure: Surgery, Drug: Carboplatin, Drug: Paclitaxel |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
- Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
- End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
- Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
- Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
Key exclusion criteria (10 listed)
- Patients with known recurrent disease outside the abdominal cavity.
- Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
- Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
- Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
- Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
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 |
|---|---|---|
| Hyperthermic intraperitoneal chemotherapy with CarboplatinCarboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes. | Drug | HIPC Treatment |
| Isotonic saline (perfusate)Also: salineThe HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius. | Other | HIPC Treatment |
| SurgeryThe abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus. If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach. | Procedure or surgery | HIPC Treatment |
| CarboplatinThe scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles. | Drug | HIPC Treatment |
| PaclitaxelAlso: TaxolThe scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles. | Drug | HIPC Treatment |
Primary outcome
Clinical Response
Time frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
Feasibility of HIPC in Recurrent Disease Setting
Time frame: 6 months
We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
3 secondary outcomes
Quality of Life Measurements
Time frame: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Progression-free Survival
Time frame: Up to 5 Years (intended)
Overall Survival
Time frame: Up to 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Argenta, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate) and Surgery in people with Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota 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 20 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Jul 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response (time frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)). The study lists 2 primary outcomes in all. 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 30 Jul 2019; AzTrials last refreshed its copy on 5 Nov 2026.