Status:
COMPLETED
Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Diseases of Oesophagus Stomach and Duodenum
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroes...
Detailed Description
Study Groups: If participant is found to be eligible to take part in this study, participant will be assigned to a dose level of paclitaxel based on when participant joins this study. Up to 8 dose le...
Eligibility Criteria
Inclusion
- Age 18 years and above. There will be no upper age restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- Adequate renal, and bone marrow function: a. Leukocytes \>= 3,000/uL b. Absolute neutrophil count \>= 1,500/uL c. Platelets \>= 60,000/Ul d. Serum creatinine \<= 1.5 mg/dL
- Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
- Completion of preoperative systemic chemotherapy.
Exclusion
- Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) 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.
- Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- Subjects deemed unable to comply with study and/or follow-up procedures.
- 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.
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03330028
Start Date
October 27 2017
End Date
April 18 2023
Last Update
April 21 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030