Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04220827

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

34.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastric Cancer AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastric Cancer AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Pathologic Stage IV Gastric Cancer AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Peritoneal Carcinomatosis Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8 Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8	Drug: Paclitaxel	Phase 1

Detailed Description

PRIMARY OBJECTIVE:

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:

Safety and tolerability of escalating doses of intraperitoneal paclitaxel in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Intraperitoneal Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Actual Study Start Date :

Dec 6, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (paclitaxel) 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.	Drug: Paclitaxel Given IP Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat

Arm

Intervention/Treatment

Experimental: Treatment (paclitaxel)

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.

Drug: Paclitaxel

Given IP

Other Names:

Anzatax

Asotax

Bristaxol

Praxel

Taxol

Taxol Konzentrat

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [Up to after 30 days after treatment completion]
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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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