Peritoneal NeoplasmsPhase 1NCT00666991
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
A Phase 1 study testing nanoparticulate paclitaxel in people with Peritoneal Neoplasms, run by CritiTech, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Neoplasms
- What is being tested?
- nanoparticulate paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to May 2013
- 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 be at least 18 years of age.
- Patients must have histologic or cytologic diagnosis of carcinoma predominantly confined to the peritoneal cavity.
- Patients must have failed all potentially curative therapy and have no other systemic treatment options available for extra-peritoneal disease. Patients with ovarian cancer that are platinum sensitive must have failed primary and at least one salvage regimen. Patients may undergo surgical debulking prior to entry into the trial.
- At least 28 days must have elapsed since completion of any other previous chemotherapy treatment received prior to registration in this study.
- Patients may have received prior abdominal surgery greater than 2 weeks prior to registration. Patients must have recovered from all effects of the surgical procedure.
- Patients must have a Zubrod Performance Status of 0 - 2.
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- Patients must have a pretreatment granulocyte count greater than or equal to 1,500/microliter and platelet count greater than or equal to 100,000/microliter obtained within 14 days prior to registration.
- Patients must have adequate renal function as documented by a serum creatinine less than or equal to 1.5 times the institutional upper limit of normal obtained within 14 days prior to registration.
- Patients must have adequate hepatic function as documented by a bilirubin of less than or equal to 2 times the institutional upper limit of normal and an SGOT less than 5 times the institutional upper limit of normal obtained within 14 days prior to registration. Patients with hepatobiliary stents are eligible for this trial if the bilirubin meets the above parameter.
- There should be no plans for the patient to receive concomitant radiation therapy, hormonal therapy, or other chemotherapy for their tumor while on this protocol.
Who cannot join
- Patients with active inflammatory bowel disease or chronic diarrhea
- Patients with uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within previous 6 months or serious uncontrolled cardiac arrhythmia
- Patients with active infection requiring systemic therapy
- Pregnant or nursing women
- Patients with Grade 2 or greater sensory neuropathy (by NCI Common Toxicity Criteria) at the time of study registration
- Patients taking concomitant medications demonstrated to inhibit or induce CYP3A4 or CYP2C8
- Patients with pre-existing conditions that prohibit the use of intravenous dexamethasone at the recommended dose
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104
Cancer Center of Kansas
Wichita, Kansas, 67208
About this study
Official title: A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.
Read the detailed description
This is an open-label, Phase 1, dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticle paclitaxel (Nanotax) in patients with refractory malignancies principally confined to the peritoneal cavity.
Nanotax will be administered via intraperitoneal infusion once every 28 days (equals one treatment cycle), continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced.
This study will treat one patient per predefined dose level until one patient experiences a dose limiting toxicity (DLT) or until one patient has a Grade 2 or higher non-hematological toxicity or a Grade 3 or higher hematological toxicity during the first cycle of treatment. At this time, two additional patients will be treated at this dose level. If these 2 additional patients do not experience a DLT, then the next cohort of three patients will be treated at the next highest dose level. If 2/3 or 3/3 patients experience a DLT then the next cohort of three patients is enrolled at the next lower dose level. If 1/3 of the patients experience a DLT, then the next cohort of three patients is enrolled at the same dose level. If 0/3 patients experience a DLT, then the next cohort of three patients is enrolled at the next highest dose level. If 2 (or more)/6 patients at a given level experience a DLT, then the maximum tolerated dose has been exceeded and another cohort of three patients is treated at the next lower dose level.
The protocol will not treat above the highest dose level of 275 mg/m2.
Adverse event data will be collected throughout the study. Peritoneal fluid and blood samples will be collected prior to Nanotax administration and up to 14 days following infusion for Cycle 1 and Cycle 2 only. Evaluation of tumor response using RECIST criteria will be conducted following each treatment cycle.
- Conditions
- Peritoneal Neoplasms
- Being tested
- nanoparticulate paclitaxel
- Keywords
- ovarian cancer, Mullerian tumors, peritoneal cavity carcinoma, gastrointestinal tract tumor, GI tract tumor, pancreatic cancer, colon cancer
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms, Digestive System Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticulate paclitaxelDrug
Also called Nanotax
This is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Nanotax, 50 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 50 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
| Nanotax, 82.5 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 82.5 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
| Nanotax, 125 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 125 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
| Nanotax, 175 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 175 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
| Nanotax, 225 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 225 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
| Nanotax 275 mg/m2 | Experimental | Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 275 mg/m2 once every 28 days until progression or unacceptable toxicity Receives: Drug: nanoparticulate paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose and to assess qualitative and quantitative toxicities
Measured: Through last patient visit
Secondary outcomes (2)
Determine preliminary anti-tumor activity using RECIST criteria
Measured: Through last patient visit
Determine pharmacokinetics of intraperitoneal administration
Measured: Up to 14 days following Cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CritiTech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center, Beckloff Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Gary Johnson, M.D., Principal investigator, University of Kansas Medical CenterJulia Chapman, M.D., Principal investigator, University of Kansas Medical CenterThomas K Schulz, M.D., Principal investigator, Cancer Center of KansasKathleen Moore, MD, Principal investigator, Peggy and Charles Stephenson Oklahoma Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666991
- Sponsor's protocol ID
- HSC#11140
- Status last verified
- Feb 2014
- First submitted
- 23 Apr 2008
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies
- ClinicalTrials.gov ID
- NCT00666991
- Acronym / sponsor ID
- HSC#11140
- Conditions
- Peritoneal Neoplasms
- Keywords
- ovarian cancer, Mullerian tumors, peritoneal cavity carcinoma, gastrointestinal tract tumor, GI tract tumor, pancreatic cancer, colon cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CritiTech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center, Beckloff Associates, Inc.
- Study start
- Jul 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Apr 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.
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.
Detailed description
This is an open-label, Phase 1, dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticle paclitaxel (Nanotax) in patients with refractory malignancies principally confined to the peritoneal cavity.
Nanotax will be administered via intraperitoneal infusion once every 28 days (equals one treatment cycle), continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced.
This study will treat one patient per predefined dose level until one patient experiences a dose limiting toxicity (DLT) or until one patient has a Grade 2 or higher non-hematological toxicity or a Grade 3 or higher hematological toxicity during the first cycle of treatment. At this time, two additional patients will be treated at this dose level. If these 2 additional patients do not experience a DLT, then the next cohort of three patients will be treated at the next highest dose level. If 2/3 or 3/3 patients experience a DLT then the next cohort of three patients is enrolled at the next lower dose level. If 1/3 of the patients experience a DLT, then the next cohort of three patients is enrolled at the same dose level. If 0/3 patients experience a DLT, then the next cohort of three patients is enrolled at the next highest dose level. If 2 (or more)/6 patients at a given level experience a DLT, then the maximum tolerated dose has been exceeded and another cohort of three patients is treated at the next lower dose level.
The protocol will not treat above the highest dose level of 275 mg/m2.
Adverse event data will be collected throughout the study. Peritoneal fluid and blood samples will be collected prior to Nanotax administration and up to 14 days following infusion for Cycle 1 and Cycle 2 only. Evaluation of tumor response using RECIST criteria will be conducted following each treatment cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nanotax, 50 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 50 mg/m2 once every 28 days until progression or unacceptable toxicity |
| Nanotax, 82.5 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 82.5 mg/m2 once every 28 days until progression or unacceptable toxicity |
| Nanotax, 125 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 125 mg/m2 once every 28 days until progression or unacceptable toxicity |
| Nanotax, 175 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 175 mg/m2 once every 28 days until progression or unacceptable toxicity |
| Nanotax, 225 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 225 mg/m2 once every 28 days until progression or unacceptable toxicity |
| Nanotax 275 mg/m2 | Experimental | Drug: nanoparticulate paclitaxelNanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 275 mg/m2 once every 28 days until progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must be at least 18 years of age.
- Patients must have histologic or cytologic diagnosis of carcinoma predominantly confined to the peritoneal cavity.
- Patients must have failed all potentially curative therapy and have no other systemic treatment options available for extra-peritoneal disease. Patients with ovarian cancer that are platinum sensitive must have failed primary and at least one salvage regimen. Patients may undergo surgical debulking prior to entry into the trial.
- At least 28 days must have elapsed since completion of any other previous chemotherapy treatment received prior to registration in this study.
- Patients may have received prior abdominal surgery greater than 2 weeks prior to registration. Patients must have recovered from all effects of the surgical procedure.
Key exclusion criteria (7 listed)
- Patients with active inflammatory bowel disease or chronic diarrhea
- Patients with uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within previous 6 months or serious uncontrolled cardiac arrhythmia
- Patients with active infection requiring systemic therapy
- Pregnant or nursing women
- Patients with Grade 2 or greater sensory neuropathy (by NCI Common Toxicity Criteria) at the time of study registration
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 |
|---|---|---|
| nanoparticulate paclitaxelAlso: NanotaxThis is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2. | Drug | Nanotax 275 mg/m2, Nanotax, 125 mg/m2, Nanotax, 175 mg/m2, Nanotax, 225 mg/m2, Nanotax, 50 mg/m2, Nanotax, 82.5 mg/m2 |
Primary outcome
Determine maximum tolerated dose and to assess qualitative and quantitative toxicities
Time frame: Through last patient visit
2 secondary outcomes
Determine preliminary anti-tumor activity using RECIST criteria
Time frame: Through last patient visit
Determine pharmacokinetics of intraperitoneal administration
Time frame: Up to 14 days following Cycles 1 and 2
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 27 Feb 2014.
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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.
Gary Johnson, M.D. principal investigator
University of Kansas Medical Center
Julia Chapman, M.D. principal investigator
University of Kansas Medical Center
Thomas K Schulz, M.D. principal investigator
Cancer Center of Kansas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nanoparticulate paclitaxel in people with Peritoneal Neoplasms, run by CritiTech, Inc. at 3 sites 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 10 inclusion and 7 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Determine maximum tolerated dose and to assess qualitative and quantitative toxicities (time frame: Through last patient visit). 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 27 Feb 2014.