NCT04220827Active, not recruitingPhase 1
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
A Phase I Study of Intraperitoneal Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
This phase I trial studies the side effects and best dose of paclitaxel for the treatment of gastric or gastroesophageal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 6 Jan 2020
- Start date
- 6 Dec 2019
- Primary completion date
- 30 Oct 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04220827
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 27
- From 6 Dec 2019 to the primary completion date, 30 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgery that would preclude safe diagnostic laparoscopy with port placement
Other illness
- Infections such as pneumonia or wound infections that would preclude protocol therapy
- Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure
- 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
Lab values
- 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-ophorectomy, 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)
Other
- Subjects deemed unable to comply with study and/or follow-up procedures
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 60,000/Ul
- Serum creatinine =\< 1.5 mg/dL
- Distant metastatic disease of peritoneum:
- Positive peritoneal cytology
- Carcinomatosis on diagnostic laparoscopy or laparotomy
- Completion of preoperative systemic chemotherapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.