Esophageal Cancer Clinical Trial
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
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.
Full Description
PRIMARY OBJECTIVE:
I. To assess the maximum tolerated dose (MTD) of paclitaxel via intraperitoneal route in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
SECONDARY OBJECTIVES:
I. Safety and tolerability of escalating doses of intraperitoneal paclitaxel in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
II. To make a preliminary assessment of the anti-tumor activity of paclitaxel in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
OUTLINE: This is a dose-escalation study.
Patients receive paclitaxel intraperitoneally (IP) over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years.
Eligibility 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
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There is 1 Location for this study
Houston Texas, 77030, United States
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