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Trial Title:
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
NCT ID:
NCT05977998
Condition:
Gastric Adenocarcinoma
Carcinomatosis
Conditions: Official terms:
Adenocarcinoma
Carcinoma
Diphenhydramine
Promethazine
Dexamethasone
Paclitaxel
Famotidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Given by IP (Intraperitoneal injection)
Arm group label:
Paclitaxel
Other name:
Taxol
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Given by IV (vein)
Arm group label:
Paclitaxel
Other name:
Decadron
Intervention type:
Drug
Intervention name:
Diphenhydramine
Description:
Given by IV (vein)
Arm group label:
Paclitaxel
Other name:
Benadryl®
Intervention type:
Drug
Intervention name:
Famotidine
Description:
Given by IV (vein)
Arm group label:
Paclitaxel
Other name:
Pepcid®
Summary:
To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part
of the stomach) on improving outcomes in patients with gastric cancer.
Detailed description:
Primary Objectives:
To assess overall survival from the date of diagnosis in subjects with stage IV gastric
or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative
intraperitoneal paclitaxel and gastrectomy.
Secondary Objectives:
To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal
cancer and positive cytology or carcinomatosis undergoing treatment with perioperative
intraperitoneal paclitaxel.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years and above. There will be no upper age restriction. Because no dosing or
adverse event data are currently available on the use of intraperitoneal paclitaxel
in patients <18 years of age, children are excluded from this study.
2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal
junction.
4. Adequate renal, and bone marrow function:
1. Leukocytes >= 3,000/uL
2. Absolute neutrophil count >= 1,500/uL
3. Platelets >= 60,000/Ul
4. Serum creatinine <= 1.6 mg/dL
5. Distant Metastatic Disease of peritoneum:
1. Positive peritoneal cytology, or
2. Carcinomatosis on diagnostic laparoscopy or laparotomy.
6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such
as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be
continued.
7. English and non-English speaking patients are eligible.
Exclusion Criteria:
1. Distant metastatic disease not limited to the peritoneum such as solid organ
metastases to the liver, central nervous system, or lung.
2. Infections such as pneumonia or wound infections that would preclude protocol
therapy.
3. Women with a positive urine or serum pregnancy test are excluded from this study;
women of childbearing potential (defined as those who are not postmenopausal defined
as no menses in greater than or equal to 12 months, have not had a hysterectomy or
bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a
surgical sterilization procedure) must agree to refrain from breast-feeding and
practice adequate contraception as specified in the informed consent. Adequate
contraception consists of oral contraceptive, implantable contraceptives, injectable
contraceptives, a double barrier method, or abstinence. Men with reproductive
potential must agree to an appropriate method of birth control, including abstinence
or double barrier method (diaphragm plus condom).
4. Subjects with unstable angina or New York Heart Association Grade II or greater
congestive heart failure.
5. Subjects, such as those with cognitive impairment, deemed unable to comply with
study and/or follow-up procedures.
6. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was
life-threatening, required hospitalization or prolongation of existing
hospitalization, or resulted in persistent or significant disability or incapacity.
7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port
placement.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hsiu-Yin Chang, RN
Phone:
713-745-7335
Email:
hchang@mdanderson.org
Investigator:
Last name:
Brian Badgwell, MD
Email:
Principal Investigator
Start date:
September 8, 2023
Completion date:
October 31, 2030
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977998
http://www.mdanderson.org
