FIGO Stage IIC-IV Ovarian CarcinomaPhase 1NCT02199171
Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer
A Phase 1 study testing carboplatin in people with FIGO Stage IIC-IV Ovarian Carcinoma and Fallopian Tube Carcinoma, run by University of California, Irvine at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- FIGO Stage IIC-IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma
- What is being tested?
- carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2017
- 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
- Patients must have histologically or cytologically confirmed, known or highly suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or interval cytoreductive surgery
- If the patient has received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: decline in serum carcinoma antigen (CA)125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s)
- Women of all races and ethnic groups are eligible for this trial
- Gynecologic Oncology Group (GOG) performance status =< 2
- Leukocytes >= 3,000/microliter (mcL)
- Absolute neutrophil count >= 1,500/mcL
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- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Albumin >= 2.5 mg/dL
- Patients for whom the diagnosis of high-grade serous or undifferentiated carcinoma of ovarian, peritoneal, or fallopian tubal origin is confirmed at surgery
- Surgery achieves either no gross residual disease or optimal cytoreductive status defined as no single lesion measuring more than 1 cm in its greatest diameter (this protocol calls for the intentional delay in resection of up to 3 tumors per patient until the HIPEC procedure is complete; the surgeon will identify these tumors as easily resectable from a technical and safety aspect)
- Patients must be stable from cardiopulmonary and hemodynamic standpoints to continue with prolonged surgery and anesthesia
- Provision of written informed consent
Who cannot join
- Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at least 3 cycles, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status), new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions, rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days)
- Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- Patients found to have non-gynecologic, uterine, or breast primary at surgery
- Patients with gynecologic malignancy of low-grade serous or borderline histology
- Patients with sub-optimal resection (any single tumor larger than 1 cm)
- Patients with core body temperature > 37 degrees Celsius (C) at completion of cytoreductive surgery and prior to HIPEC
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- Patients who are receiving other investigational therapeutic agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it directly into the area around the tumor during surgery may kill more tumor cells.
Read the detailed description
Primary Objectives:
To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers.
Secondary Objectives:
- To determine the dose limiting toxicities of HIPEC carboplatin.
- To describe the pharmacokinetic profile of HIPEC carboplatin.
- To quantify changes in tissue temperature during HIPEC and compare to conventional temperature measures (esophageal and bladder).
- To describe the extent of thermal damage and DNA platinum adduct formation in tissues resulting from HIPEC carboplatin.
OUTLINE: This is a dose escalation study.
Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
- Being tested
- carboplatin
- Keywords
- hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) carboplatin, intraperitoneal (IP) chemotherapy, cytoreductive surgery
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called (SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O']platinum, 1,1-cyclobutanedicarboxylic acid platinum complex, 19314, 241240, 41575-94-4
Given via HIPEC
| Study group | Role | What they receive |
|---|---|---|
| HIPEC carboplatin | Experimental | Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
Doses as appropriate for assigned dose level in 500 cubic centimeters (cc) Receives: Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of HIPEC carboplatin
MTD of HIPEC carboplatin, defined as the dose level with < 2 patients of 6 experiencing dose-limiting toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Identified using the continual reassessment method.
Measured: Up to 30 days after study treatment
Secondary outcomes (7)
Disease control rates, scored according to Response Evaluation Criteria in Solid Tumors criteria and consist of complete response, partial response, and stable disease
Measured: Up to 1 year
1-year overall survival (OS) rate
For 1-year OS rate, death events will be recorded. One-year OS rate will be defined by the number of participants alive 1 year from the time of study entry.
Measured: At 1 year
Incidence of adverse events assessed using Common Toxicity Criteria version 4.0
Participants who receive any amount of study drug will be evaluable for toxicity.
Measured: Up to 30 days after study treatment
Change in pharmacokinetic profile of HIPEC carboplatin
Median, range, and interquartile range will be calculated and reported for the amount of carboplatin absorbed from the perfusate, the rate of drug absorption from the peritoneal cavity into the systemic circulation, the 0-to-60 minute area under the curve (AUCs) for peritoneal and plasma platinum concentration curves, the total body clearance, the 0-to-24 hour AUC for filterable platinum in the plasma, and regional advantage. Estimates of population averages will be calculated and reported using 95% confidence intervals.
Measured: Baseline and at 5, 15, 30, 45, and 60 minutes
Changes in tissue temperature during HIPEC compared to conventional temperature measures (esophageal and bladder)
Measured at in situ tumor sites and at esophageal and bladder tissue (controls). Median, range and interquartile range will be calculated and reported for mean and peak temperature. Average within-patient paired differences of mean temperature will be summarized descriptively. Estimates of the population average difference in mean temperature between tumor and control tissue will be calculated and reported with 95% confidence intervals. Frechet or type-II extreme value distributions will be used to model the peak temperature as measured in tumor sites.
Measured: Baseline to after completion of HIPEC
Extent of DNA platinum adduct formation in tissues resulting from HIPEC carboplatin
Platinum levels will be measured by inductively coupled plasma mass spectrometry (ICP-MS). Median, range and interquartile range will be calculated and reported for platinum levels per tumor wet weight and per tumor volume. Estimates of population average platinum level will be calculated and reported with 95% confidence intervals as based on measured values or transformed values and the normal approximation.
Measured: After HIPEC but before the subject leaves the operating room (up to 2 hours)
Thermal damage in tissues resulting from HIPEC carboplatin
A linear model will be calculated and reported for the regression of log-transformed total depth of destruction on per-patient mean temperature as measured during perfusion at in-situ tumor sites.
Measured: After HIPEC but before the subject leaves the operating room (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FIGO Stage IIC-IV Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishnansu, University of California, Irvine
- Investigators
- Krishnansu Tewari, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199171
- Sponsor's protocol ID
- UCI 13-54 HS# 2014-1188
- Other IDs
- 2014-1188
- Status last verified
- Jan 2020
- First submitted
- 16 Jul 2014
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.
- ClinicalTrials.gov ID
- NCT02199171
- Acronym / sponsor ID
- UCI 13-54 HS# 2014-1188
- Keywords
- hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) carboplatin, intraperitoneal (IP) chemotherapy, cytoreductive surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Jul 2014 (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.
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it directly into the area around the tumor during surgery may kill more tumor cells.
Detailed description
Primary Objectives:
To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers.
Secondary Objectives:
- To determine the dose limiting toxicities of HIPEC carboplatin.
- To describe the pharmacokinetic profile of HIPEC carboplatin.
- To quantify changes in tissue temperature during HIPEC and compare to conventional temperature measures (esophageal and bladder).
- To describe the extent of thermal damage and DNA platinum adduct formation in tissues resulting from HIPEC carboplatin.
OUTLINE: This is a dose escalation study.
Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC carboplatin | Experimental | Drug: carboplatinPatients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure. Doses as appropriate for assigned dose level in 500 cubic centimeters (cc) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed, known or highly suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or interval cytoreductive surgery
- If the patient has received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: decline in serum carcinoma antigen (CA)125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s)
- Women of all races and ethnic groups are eligible for this trial
- Gynecologic Oncology Group (GOG) performance status =< 2
- Leukocytes >= 3,000/microliter (mcL)
Key exclusion criteria (9 listed)
- Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at least 3 cycles, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status), new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions, rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days)
- Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- Patients found to have non-gynecologic, uterine, or breast primary at surgery
- Patients with gynecologic malignancy of low-grade serous or borderline histology
- Patients with sub-optimal resection (any single tumor larger than 1 cm)
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 |
|---|---|---|
| carboplatinAlso: (SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O']platinum, 1,1-cyclobutanedicarboxylic acid platinum complex, 19314, 241240, 41575-94-4Given via HIPEC | Drug | HIPEC carboplatin |
Primary outcome
Maximum tolerated dose (MTD) of HIPEC carboplatin
Time frame: Up to 30 days after study treatment
MTD of HIPEC carboplatin, defined as the dose level with < 2 patients of 6 experiencing dose-limiting toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Identified using the continual reassessment method.
7 secondary outcomes
Disease control rates, scored according to Response Evaluation Criteria in Solid Tumors criteria and consist of complete response, partial response, and stable disease
Time frame: Up to 1 year
1-year overall survival (OS) rate
Time frame: At 1 year
Incidence of adverse events assessed using Common Toxicity Criteria version 4.0
Time frame: Up to 30 days after study treatment
Change in pharmacokinetic profile of HIPEC carboplatin
Time frame: Baseline and at 5, 15, 30, 45, and 60 minutes
Changes in tissue temperature during HIPEC compared to conventional temperature measures (esophageal and bladder)
Time frame: Baseline to after completion of HIPEC
Extent of DNA platinum adduct formation in tissues resulting from HIPEC carboplatin
Time frame: After HIPEC but before the subject leaves the operating room (up to 2 hours)
Thermal damage in tissues resulting from HIPEC carboplatin
Time frame: After HIPEC but before the subject leaves the operating room (up to 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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.
Krishnansu Tewari, MD principal investigator
University of California, Irvine
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 carboplatin in people with FIGO Stage IIC-IV Ovarian Carcinoma and Fallopian Tube Carcinoma, run by University of California, Irvine 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 15 inclusion and 9 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: finished, as of the sponsor's last update on 31 Jan 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of HIPEC carboplatin (time frame: Up to 30 days after study treatment). 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 31 Jan 2020.