Clinical trial · Interventional
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
NCT04220827CI-TRIAL-00108356active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage IVA Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IVB Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IV Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Metastatic Gastric Adenocarcinoma | Gastric Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel)
- description
- Patients receive paclitaxel IP over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- Up to after 30 days after treatment completion
- description
- Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Safety data will be summarized using frequency tables by grade and attribution.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 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) * 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 * Previous surgery that would preclude safe diagnostic laparoscopy with port placement
References
Publications (0)
Data not yet available
No reference posted for this study.