Recurrent Ovarian CancerPhase 2HIPECNCT01659554
A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers
A Phase 2 study testing Cisplatin and Doxorubicin in people with Recurrent Ovarian Cancer and Fallopian Tube Cancer, run by Columbia University at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Cisplatin and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
- Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
- Patients must fulfill the following with regard to prior chemotherapy:
- 4 weeks or greater since conclusion of prior chemotherapy;
- Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,
- Prior systemic chemotherapy is acceptable.
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- Patients must have a Karnofsky Performance Status of > 70%
- Patients must have an estimated life expectancy of at least 16 weeks.
- Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
- Patients must have adequate organ function at the screening visit as defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥8 g/dL Albumin ≥ 2 g/dL Total Bilirubin ≤ 2.5 x ULN Alkaline phosphatase ≤ 3.0 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN Creatinine ≤ 1.5 x ULN
- Patient must have signed informed consent
- Patient must be at least 18 years of age
- Following cytoreductive surgery, patient's residual disease should be no larger than 1cm to Receive HIPEC and continue with normothermic IP chemotherapy
Who cannot join
- Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 4).
- Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure (see section 16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Prior radiation therapy within 4 weeks of enrollment.
- Have uncontrolled active systemic infection requiring therapy.
- Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
- Have had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
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- Have had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- Have had any investigational agent within 4 weeks before enrollment into the study.
- Have a history of a serious medical or psychiatric illness preventing informed consent or, in the opinion of the investigator, would make the patient a poor study candidate.
- Evidence of extraabdominal metastasis on preinclusion thoracic computed tomography (CT) scans (i.e. brain or chest disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers
The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.
Read the detailed description
This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.
- Conditions
- Recurrent Ovarian Cancer, Fallopian Tube Cancer
- Being tested
- Cisplatin, Doxorubicin
- Keywords
- Primary peritoneal
- 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.
CisplatinDrug
Also called cis-diamminedichloroplatinum(II) (CDDP), Platinol, Platinol-AQ
Cisplatin (75 mg/m2) prepared in 2L normal saline.
DoxorubicinDrug
Also called hydroxyldaunorubicin, Adriamycin
Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).
| Study group | Role | What they receive |
|---|---|---|
| Out-Patient Intraperitoneal Chemotherapy | Experimental | Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle. Receives: Drug: Cisplatin; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate and/or Laboratory Changes
The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.
Measured: 5 years
Toxicity Rating Based on NCI Common Toxicity Criteria
Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).
Measured: Up to 5 years
Secondary outcomes (2)
Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)
Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.
Measured: Up to 5 years (survival)
Kaplan-Meier Curves for Patient Overall Survival
Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).
Measured: Up to 5 years, survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Principal Investigator left institution
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 Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharyn Lewin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659554
- Sponsor's protocol ID
- AAAI1246
- Acronym
- HIPEC
- Status last verified
- Jan 2017
- First submitted
- 10 Jul 2012
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers
- ClinicalTrials.gov ID
- NCT01659554
- Acronym / sponsor ID
- HIPEC / AAAI1246
- Conditions
- Recurrent Ovarian Cancer, Fallopian Tube Cancer
- Keywords
- Primary peritoneal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Posted 3 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.
Detailed description
This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-Patient Intraperitoneal Chemotherapy | Experimental | Drug: Cisplatin, Drug: DoxorubicinIntraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
- Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
- Patients must fulfill the following with regard to prior chemotherapy:
- Patients must have a Karnofsky Performance Status of > 70%
- Patients must have an estimated life expectancy of at least 16 weeks.
Key exclusion criteria (10 listed)
- Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 4).
- Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure (see section 16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Prior radiation therapy within 4 weeks of enrollment.
- Have uncontrolled active systemic infection requiring therapy.
- Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
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: cis-diamminedichloroplatinum(II) (CDDP), Platinol, Platinol-AQCisplatin (75 mg/m2) prepared in 2L normal saline. | Drug | Out-Patient Intraperitoneal Chemotherapy |
| DoxorubicinAlso: hydroxyldaunorubicin, AdriamycinDoxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based). | Drug | Out-Patient Intraperitoneal Chemotherapy |
Primary outcome
Adverse Event Rate and/or Laboratory Changes
Time frame: 5 years
The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.
Toxicity Rating Based on NCI Common Toxicity Criteria
Time frame: Up to 5 years
Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).
2 secondary outcomes
Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)
Time frame: Up to 5 years (survival)
Kaplan-Meier Curves for Patient Overall Survival
Time frame: Up to 5 years, survival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sharyn Lewin, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Doxorubicin in people with Recurrent Ovarian Cancer and Fallopian Tube Cancer, run by Columbia University 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 14 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 10 Mar 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2015). 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?
Adverse Event Rate and/or Laboratory Changes (time frame: 5 years). 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 10 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.