Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peritoneal Neoplasms |
Drug: nanoparticulate paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies |
- Determine maximum tolerated dose and to assess qualitative and quantitative toxicities [ Time Frame: Through last patient visit ] [ Designated as safety issue: Yes ]
- Determine preliminary anti-tumor activity using RECIST criteria [ Time Frame: Through last patient visit ] [ Designated as safety issue: No ]
- Determine pharmacokinetics of intraperitoneal administration [ Time Frame: Up to 14 days following Cycles 1 and 2 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: nanoparticulate paclitaxel
sterile suspension of nanoparticulate paclitaxel administered intraperitoneally on Day 1 of each 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Other Name: Nanotax
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Cancer Center of Kansas | |
| Wichita, Kansas, United States, 67208 | |
| United States, Oklahoma | |
| Peggy and Charles Stephenson Oklahoma Cancer Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Gary Johnson, M.D. | University of Kansas |
| Principal Investigator: | Julia Chapman, M.D. | University of Kansas |
| Principal Investigator: | Thomas K Schulz, M.D. | Cancer Center of Kansas |
| Principal Investigator: | Kathleen Moore, MD | Peggy and Charles Stephenson Oklahoma Cancer Center |
More Information
No publications provided
| Responsible Party: | CritiTech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00666991 History of Changes |
| Obsolete Identifiers: | NCT00708864 |
| Other Study ID Numbers: | HSC#11140 |
| Study First Received: | April 23, 2008 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CritiTech, Inc.:
|
ovarian cancer Mullerian tumors peritoneal cavity carcinoma gastrointestinal tract tumor |
GI tract tumor pancreatic cancer colon cancer |
Additional relevant MeSH terms:
|
Neoplasms Peritoneal Neoplasms Abdominal Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013