This study is NOT currently recruiting participants.
Number
19-C-0129
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Pregnant Women;Children
Keywords
Gastroesophageal Junction (Siewert I-III) Adenocarcinoma; Intravenous Chemotherapy; Progression Free Survival; Peritoneal Metastasis; Intraperitoneal Chemotherapy
Recruitment Keyword(s)
None
Condition(s)
Gastric Adenocarcinoma; Gastric Cancer; Esophagogastric Junction; Peritoneal Carcinomatosis
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Paclitaxel Drug: Capecitabine Device: BardPort Titanium Implanted Port with Peritoneal Catheter
Supporting Site
National Cancer Institute
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.
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INCLUSION CRITERIA: 1. 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. 2. Patients may be treatment na(SqrRoot) ve or have received systemic chemotherapy prior to enrollment: -Trastuzumab allowed as prior treatment for human epidermal growth factor receptor 2 (HER2)/neu over-expressing cancers as clinically indicated. -Last dose of chemotherapy at least 2 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. Eastern Cooperative Oncology Group (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 Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (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. 7. Physiologically able to undergo laparoscopy and systemic chemotherapy. 8. Ability of subject to understand and the willingness to sign a written informed consent document. 9. Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted. 10. 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. 11. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and 17C0044 (NCT03027427) for sample collection. 12. HIV-positive patients may be considered for this study only after consultation with a National Institute of Allergy and Infectious Diseases (NIAID) physician. EXCLUSION CRITERIA: 1. Patients who are receiving any other investigational agents. 2. Previous cytoreductive surgery or intraperitoneal chemotherapy. 3. Disseminated extra-peritoneal or solid organ metastases: -Excludes greater omentum and ovarian metastases. -Radiographic signs or clinical symptoms consistent with malignant bowel obstruction. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study. 5. Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease. 6. Existing peripheral neuropathy, Grade 3 or greater. 7. Past medical history of dihydropyrimidine dehydrogenase deficiency. 8. 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. 9. 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.
1. 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.
2. Patients may be treatment na(SqrRoot) ve or have received systemic chemotherapy prior to enrollment:
-Trastuzumab allowed as prior treatment for human epidermal growth factor receptor 2 (HER2)/neu over-expressing cancers as clinically indicated.
-Last dose of chemotherapy at least 2 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. Eastern Cooperative Oncology Group (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
Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (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.
7. Physiologically able to undergo laparoscopy and systemic chemotherapy.
8. Ability of subject to understand and the willingness to sign a written informed consent document.
9. Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted.
10. 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.
11. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and 17C0044 (NCT03027427) for sample collection.
12. HIV-positive patients may be considered for this study only after consultation with a National Institute of Allergy and Infectious Diseases (NIAID) physician.
EXCLUSION CRITERIA:
1. Patients who are receiving any other investigational agents.
2. Previous cytoreductive surgery or intraperitoneal chemotherapy.
3. Disseminated extra-peritoneal or solid organ metastases:
-Excludes greater omentum and ovarian metastases.
-Radiographic signs or clinical symptoms consistent with malignant bowel obstruction.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study.
5. Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease.
6. Existing peripheral neuropathy, Grade 3 or greater.
7. Past medical history of dihydropyrimidine dehydrogenase deficiency.
8. 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.
9. 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.
Principal Investigator
Referral Contact
For more information: