Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04583488|
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : November 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Carcinomatosis||Drug: Intraperitoneal docetaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Intraperitoneal Docetaxel in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) for Gastric Cancer Patients With Peritoneal Carcinomatosis|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2026|
Experimental: Intraperitoneal docetaxel
Participants will receive intraperitoneal docetaxel combined with the standard of care. A standard 3 + 3 dose escalation design will be used according to the dose escalation plan.
Drug: Intraperitoneal docetaxel
Up to 3 dose levels of intraperitoneal docetaxel will be studied (45mg/m2, 65 mg/m2, 85 mg/m2).
Other Name: Taxotere
- Maximum Tolerated Dose (MTD) [ Time Frame: 20 weeks ]To determine the Maximum Tolerated Dose (MTD) of intraperitoneal docetaxel in conjunction with the standard of care treatment regimen of intravenous mFOLFOX6 in patients with primary gastric cancer with gross peritoneal carcinomatosis
- Progression-Free Survival [ Time Frame: 20 weeks ]Progression-free survival rate at 20 weeks, which is defined as the percentage of patients alive and free of disease progression at 20 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583488
|Contact: Fabian M Johnston, MD, MHSfirstname.lastname@example.org|
|Contact: Sherry Leungemail@example.com|
|Principal Investigator:||Fabian M Johnston, MD, MHS||Johns Hopkins University|