Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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