Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

  • STATUS
    Recruiting
  • End date
    Jan 30, 2027
  • participants needed
    70
  • sponsor
    National Cancer Institute (NCI)
Updated on 28 September 2020
laparotomy
paclitaxel
cancer
endoscopy
metastasis
gastric adenocarcinoma
neutrophil count
capecitabine
adenocarcinoma of the gastroesophageal junction
trastuzumab
gastric cancer
laparoscopy
human epidermal growth factor
systemic chemotherapy
adenocarcinoma
erbb2
peritoneal carcinomatosis
staging laparoscopy

Summary

Background

Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow.

Objective

To find a better way to treat advanced stomach cancer.

Eligibility

People ages 18 and older with stomach cancer that has spread throughout their belly.

Design

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

Scans

Cancer sample: If they do not have one, they will have a biopsy.

Tests of performance of normal activities

Dietary assessment

Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen.

Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer.

Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle.

After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy.

Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.

Description

Background
  • An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the U.S.
  • Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients.
  • Systemic chemotherapy is the recommended treatment for patients with metastatic gastric cancer to the peritoneal cavity, however selective use of cytoreductive surgery and intraperitoneal chemotherapy has been associated with improved overall survival.
  • Multiple chemotherapeutic agents and delivery systems have been described for intraperitoneal therapy, but no standard regimen exists.
    Objective

-Determine the progression free survival (PFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy.

Eligibility
  • Histologically confirmed adenocarcinoma of the stomach.
  • Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy.
  • Medically fit for systemic chemotherapy and intraperitoneal chemotherapy.
  • Men and women agegreater than or equal to 18 years.
Design
  • Phase II, nonrandomized, open label study.
  • Patients will enroll in two cohorts: those with prior systemic chemotherapy and those who are treatment naive.
  • Patients will undergo staging laparoscopy and placement of peritoneal access port.
  • Intraperitoneal paclitaxel (20 mg/m2 weekly), intravenous paclitaxel (80 mg/m2 weekly), and capecitabine (825 mg/m2 twice daily for 14 days of each cycle) for 12 weeks.
  • Treatment response will be assessed with imaging and laparoscopy.
  • It is expected that 16-20 patients per year for total 4 years will be enrolled. The accrual ceiling is set at 70 patients.

Details
Treatment Capecitabine, Paclitaxel, BardPort Titanium Implanted Port withPeritoneal Catheter
Clinical Study IdentifierNCT04034251
SponsorNational Cancer Institute (NCI)
Last Modified on28 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Abdominal Neoplasm or Gastropathy or Gastroesophageal Junction or Peritoneal Carcinomatosis or Gastric Cancer or Neoplasm of unspecified nature of dig...?
Patients must have histologically or cytologically confirmed gastric adenocarcinoma, including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the NCI Laboratory of Pathology, and have provided a block or unstained slides of primary or
metastatic tumor tissue or newly obtained fresh biopsy of a tumor lesion in
case archival tissue sample is not available
\. Patients may be treatment na(SqrRoot) ve or have received systemic
chemotherapy prior to enrollment
Trastuzumab allowed as prior treatment for HER2/neu over-expressing cancers as clinically indicated
Last dose of chemotherapy at least 4 weeks prior to enrollment with recovery to Grade 1 from chemotherapy-related toxicities. 3\. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy. 4\. Age >=18 years. Children under the age of 18 will not participate in this study as gastric cancer is rare in this population. 5\. ECOG performance status <=1 6\. Patients must have normal organ and marrow function as defined below
hemoglobin >=8.0 g/dL
absolute neutrophil count >=1,000/mcL
platelets >=100,000/mcL
total bilirubin <=1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal
creatinine <1.5 mg/dl
OR
creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels
above institutional normal
\. Physiologically able to undergo laparoscopy and systemic chemotherapy
\. Ability of subject to understand and the willingness to sign a written
informed consent document
\. Previous exploratory laparotomy or laparoscopy with tissue biopsy or
peritoneal lavage is permitted
\. Women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior
to study entry and for the duration of study treatment. Should a woman become
pregnant or suspect she is pregnant while she or her partner is participating
in this study, she should inform her treating physician immediately
\. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and
C0044 (NCT03027427) for sample collection
\. HIV-positive patients may be considered for this study only after
consultation with a NIAID physician

Exclusion Criteria

Patients who are receiving any other investigational agents
Previous cytoreductive surgery or intraperitoneal chemotherapy
Disseminated extra-peritoneal or solid organ metastases
Excludes greater omentum and ovarian metastases
Radiographic signs or clinical symptoms consistent with malignant bowel obstruction
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study
Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease
Existing peripheral neuropathy, Grade 3 or greater
Past medical history of dihydropyrimidine dehydrogenase deficiency
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients on therapeutic anticoagulation; Note: Prophylactic anticoagulation (i.e. intralumenal heparin) for venous or arterial access devices is allowed
Pregnant women are excluded because paclitaxel and capecitabine can cause fetal harm when administered to pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel and capecitabine, breastfeeding should be discontinued if the mother is treated with paclitaxel and capecitabine
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