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| ID | Type | Description | Link |
|---|---|---|---|
| CHNMC-08059 | |||
| ABRAXIS-CHNMC-08059 | |||
| NCCN-A02 | |||
| CDR0000632797 | Registry Identifier | NCI PDQ | |
| NCI-2010-00921 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Comprehensive Cancer Network | NETWORK |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of nab-paclitaxel as a single agent administered intraperitoneally via an intraperitoneal catheter.
SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in the plasma and peritoneum when it is administered directly into the peritoneal cavity. II. To determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel (Abraxane) concentration in the peritoneal cavity vs. plasma) for nab-paclitaxel administered intraperitoneally. III. To determine the progression of peripheral neuropathy in patients treated with intraperitoneal chemotherapy on this study through pre-treatment and sequential evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve Conduction Studies.
OUTLINE: This is a dose-escalation study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation given intraperitoneally (IP) on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel albumin-stabilized nanoparticle) | Experimental | Patients receive paclitaxel albumin-stabilized nanoparticle formulation given IP on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Given IP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and maximum-tolerated dose | The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and course. | 28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Response according to Response Evaluation Criteria in Solid Tumors (RECIST) | All responses will be reported; because of the potential heterogeneity of the patients, no attempt will be made to estimate the response rate. | 4 weeks after completion of the last course of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (area under the curve [AUC], pharmacological advantage, and clearance in the plasma and peritoneum) | Will be summarized by dose level with simple summary statistics: means (possibly after transformation) or medians, ranges, and standard deviations (if numbers and distribution permit). | Course 1 days 1 and 15 at 1, 2, 4, 6, 8, 12, 24, and 48 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihaela Cristea, MD | City of Hope Medical Center | Principal Investigator |
| Mihaela Cristea, MD | City of Hope Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States | ||
| Swedish Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30623229 | Derived | Cristea MC, Frankel P, Synold T, Rivkin S, Lim D, Chung V, Chao J, Wakabayashi M, Paz B, Han E, Lin P, Leong L, Hakim A, Carroll M, Prakash N, Dellinger T, Park M, Morgan RJ. A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Cancer Chemother Pharmacol. 2019 Mar;83(3):589-598. doi: 10.1007/s00280-019-03767-9. Epub 2019 Jan 8. |
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| liquid chromatography | Other | Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion. |
|
| mass spectrometry | Other | Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion. |
|
| pharmacological study | Other | Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion. |
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Pharmacodynamic (AUC, pharmacological advantage, and clearance in the plasma and peritoneum) | Will be summarized by dose level with simple summary statistics: means (possibly after transformation) or medians, ranges, and standard deviations (if numbers and distribution permit). | Course 1 days 1 and 15 at 1, 2, 4, 8, 12, 24 and 48 hours |
| Seattle |
| Washington |
| 98104 |
| United States |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002853 | Chromatography, Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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