Peritoneal Cavity CancerPhase 1NCT00625092
Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies
A Phase 1 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Peritoneal Cavity Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Cavity Cancer
- What is being tested?
- fluorouracil, leucovorin calcium and oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologic proof of peritoneal metastases (includes adenomucinosis)
- Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation)
- Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose.
- Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study.
- Patients must have a Karnofsky performance score of ≥ 80%.
- Adequate hematologic, renal and hepatic function within 14 days of registration defined as:
Show all 12Show fewer
- White blood count (WBC) ≥ 3,000
- platelet count ≥ 70,000,
- serum bilirubin ≤ 2.0 mg/dL,
- serum creatinine ≤ 1.5 mg/dL
- Patients must be at least 18 years of age
- Patients must be able to provide informed consent
Who cannot join
- Metastatic disease is present outside the peritoneal cavity
- Diagnosis of mesothelioma
- Grade 2 or higher sensory neuropathy at time of study enrollment
- History of allergic reaction to platinum compounds
- Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy.
- Previous peritoneal chemotherapy.
- Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration).
- Patients have psychiatric or addictive disorders that preclude obtaining informed consent.
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: Phase I Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the safety and optimal dose of hyperthermic intraperitoneal oxaliplatin when administered during cytoreductive surgery and followed by intraperitoneal leucovorin calcium and fluorouracil in patients with peritoneal malignancies.
Secondary
- To determine the outcome of cytoreductive surgery in these patients.
- To determine the time to disease progression and pattern of failure in patients treated with this regimen.
- To determine the 1 and 5 year survival in patients treated with this regimen.
- To compare quality-of-life pre- and post-surgery in these patients.
- To characterize total- and free-platinum pharmacokinetics in the plasma and total platinum in the intraperitoneal space at baseline, during, and after hyperthermic intraperitoneal chemotherapy (HIPC).
- To assess for the presence of genetic polymorphisms in the XDP and XRCC1 DNA repair genes.
- To assess tumor and normal tissue concentrations for total platinum obtained at baseline and immediately after HIPC.
OUTLINE:
- Cytoreductive Surgery: Patients undergo an exploratory laparotomy to remove all tumor nodules from all peritoneal surfaces prior to gastrointestinal anastomoses. An intraperitoneal drain is placed for postoperative intraperitoneal chemotherapy.
- Hyperthermic peritoneal chemotherapy (HIPC): After cytoreductive surgery, but before intestinal anastomosis, patients receive oxaliplatin into the abdomen cavity at approximately 1 liter/min at 41-42º C and held for 30 minutes at the maximum tolerated dose. A heat exchanger maintains the fluid temperature at 44-46º C to maintain the intraperitoneal temperature at 41-42º C. Patients may receive fluid challenges, furosemide, mannitol, or renal dose dopamine to maintain a brisk diuresis at the discretion of the anesthesiologist.
- Intraperitoneal chemotherapy: After HIPC, patients receive leucovorin calcium intraperitoneally through an intraperitoneal drain where it will remain for 2 hours and then drained. Patients then receive fluorouracil intraperitoneally through the intraperitoneal drain on day 1 and remain in the peritoneal fluid for 23 hours and then drained. The infusion will be repeated on day 2.
Blood samples are collected prior to surgery for pharmacogenetic studies and analyzed for the presence of genetic polymorphisms in the XPD and XRCC1 DNA repair genes and the GSTP1 and GSTM1 glutathione-S-transferase enzymes (i.e., XPD, Asp312Asn, XPD K751Q, XRCC1 Arg399GIn, XRCC1 Arg399Q, GSTP1 l105V, and GSTM1 DEL). Blood samples are also collected periodically for pharmacokinetic studies and analyzed for oxaliplatin concentrations. Normal and tumor tissue are collected periodically and analyzed for total platinum concentrations.
Quality of life is assessed at baseline and at 4, 8, and 12 months.
After completion of study treatment, patients are followed every 4 months for 2 years and then every 6 months for at least 5 years.
- Conditions
- Peritoneal Cavity Cancer
- Being tested
- fluorouracil, leucovorin calcium, oxaliplatin, cytoreductive surgery
- Keywords
- peritoneal cavity cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Also called 5-FU
Post-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours
Day 0 200 mg/m^2 intraperitoneal held for 2 hours
oxaliplatinDrug
Also called Eloxatin
Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2
cytoreductive surgeryProcedure or surgery
Also called conventional surgery
Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic Treatment | Experimental | Patients receiving combination of hyperthermic intraperitoneal chemotherapy (HIPC) with oxaliplatin plus intraperitoneal 5-Fu and intraperitoneal leucovorin with peritoneal metastases. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of hyperthermic intraperitoneal oxaliplatin
Measured: 30 Days Post Treatment
Secondary outcomes (3)
Changes in quality-of-life
Using the Functional Assessment of Cancer Therapy for Colorectal Cancer (FACT-C) and SF-36 (Quality of Life Evaluation in Dialysis Patients) questionnaires, the quality of life following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPC) will be reported and compared to the preoperative baseline.
Measured: Baseline and at 4, 8, and 12 months
Overall survival
Measured: 1 Year and 5 Years
Time to Disease Progression
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Cavity CancerStudies of the same condition, open and under way.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd M. Tuttle, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625092
- Sponsor's protocol ID
- 2005LS068
- Other IDs
- 0601M79448
- Status last verified
- Nov 2017
- First submitted
- 27 Feb 2008
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies
- ClinicalTrials.gov ID
- NCT00625092
- Acronym / sponsor ID
- 2005LS068
- Conditions
- Peritoneal Cavity Cancer
- Keywords
- peritoneal cavity cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Feb 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the safety and optimal dose of hyperthermic intraperitoneal oxaliplatin when administered during cytoreductive surgery and followed by intraperitoneal leucovorin calcium and fluorouracil in patients with peritoneal malignancies.
Secondary
- To determine the outcome of cytoreductive surgery in these patients.
- To determine the time to disease progression and pattern of failure in patients treated with this regimen.
- To determine the 1 and 5 year survival in patients treated with this regimen.
- To compare quality-of-life pre- and post-surgery in these patients.
- To characterize total- and free-platinum pharmacokinetics in the plasma and total platinum in the intraperitoneal space at baseline, during, and after hyperthermic intraperitoneal chemotherapy (HIPC).
- To assess for the presence of genetic polymorphisms in the XDP and XRCC1 DNA repair genes.
- To assess tumor and normal tissue concentrations for total platinum obtained at baseline and immediately after HIPC.
OUTLINE:
- Cytoreductive Surgery: Patients undergo an exploratory laparotomy to remove all tumor nodules from all peritoneal surfaces prior to gastrointestinal anastomoses. An intraperitoneal drain is placed for postoperative intraperitoneal chemotherapy.
- Hyperthermic peritoneal chemotherapy (HIPC): After cytoreductive surgery, but before intestinal anastomosis, patients receive oxaliplatin into the abdomen cavity at approximately 1 liter/min at 41-42º C and held for 30 minutes at the maximum tolerated dose. A heat exchanger maintains the fluid temperature at 44-46º C to maintain the intraperitoneal temperature at 41-42º C. Patients may receive fluid challenges, furosemide, mannitol, or renal dose dopamine to maintain a brisk diuresis at the discretion of the anesthesiologist.
- Intraperitoneal chemotherapy: After HIPC, patients receive leucovorin calcium intraperitoneally through an intraperitoneal drain where it will remain for 2 hours and then drained. Patients then receive fluorouracil intraperitoneally through the intraperitoneal drain on day 1 and remain in the peritoneal fluid for 23 hours and then drained. The infusion will be repeated on day 2.
Blood samples are collected prior to surgery for pharmacogenetic studies and analyzed for the presence of genetic polymorphisms in the XPD and XRCC1 DNA repair genes and the GSTP1 and GSTM1 glutathione-S-transferase enzymes (i.e., XPD, Asp312Asn, XPD K751Q, XRCC1 Arg399GIn, XRCC1 Arg399Q, GSTP1 l105V, and GSTM1 DEL). Blood samples are also collected periodically for pharmacokinetic studies and analyzed for oxaliplatin concentrations. Normal and tumor tissue are collected periodically and analyzed for total platinum concentrations.
Quality of life is assessed at baseline and at 4, 8, and 12 months.
After completion of study treatment, patients are followed every 4 months for 2 years and then every 6 months for at least 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic Treatment | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Procedure: cytoreductive surgeryPatients receiving combination of hyperthermic intraperitoneal chemotherapy (HIPC) with oxaliplatin plus intraperitoneal 5-Fu and intraperitoneal leucovorin with peritoneal metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologic proof of peritoneal metastases (includes adenomucinosis)
- Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation)
- Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose.
- Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study.
- Patients must have a Karnofsky performance score of ≥ 80%.
Key exclusion criteria (8 listed)
- Metastatic disease is present outside the peritoneal cavity
- Diagnosis of mesothelioma
- Grade 2 or higher sensory neuropathy at time of study enrollment
- History of allergic reaction to platinum compounds
- Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study 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 |
|---|---|---|
| fluorouracilAlso: 5-FUPost-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours | Drug | Hyperthermic Treatment |
| leucovorin calciumDay 0 200 mg/m^2 intraperitoneal held for 2 hours | Drug | Hyperthermic Treatment |
| oxaliplatinAlso: EloxatinDay 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2 | Drug | Hyperthermic Treatment |
| cytoreductive surgeryAlso: conventional surgeryDay 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules. | Procedure or surgery | Hyperthermic Treatment |
Primary outcome
Maximum tolerated dose of hyperthermic intraperitoneal oxaliplatin
Time frame: 30 Days Post Treatment
3 secondary outcomes
Changes in quality-of-life
Time frame: Baseline and at 4, 8, and 12 months
Overall survival
Time frame: 1 Year and 5 Years
Time to Disease Progression
Time frame: Monthly
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 29 Nov 2017.
Related trials for Peritoneal Cavity Cancer
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
Active, not recruitingPhase 2
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Ovary Cancer, Fallopian Tube Cancer
RecruitingObservational study
Real-World Study of Mirvetuximab Soravtansine in Adult Participants With Platinum-Resistant FRα-Positive Ovarian, Fallopian Tube, and Peritoneal Cancer
Platinum-Resistant FRα-Positive Ovarian Cancer, Platinum-Resistant FRα-Positive Fallopian Tube Cancer
Active, not recruitingPhase 2/3
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma
RecruitingObservational study
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
Peritoneal (Metastatic) Cancer, Colorectal Cancer
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.
Todd M. Tuttle, 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 Phase 1 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Peritoneal Cavity 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 12 inclusion and 8 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 29 Nov 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 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 of hyperthermic intraperitoneal oxaliplatin (time frame: 30 Days Post 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 29 Nov 2017.