Trial Summary
What is the purpose of this trial?This is a phase II clinical trial assessing the safety and efficacy of sequential systemic and intraperitoneal (IP) chemotherapy in patients with primary gastric/gastroesophageal junction cancer with cytology positive peritoneal lavage and/or peritoneal carcinomatosis.
Is the drug combination of Fluorouracil, Leucovorin, and Paclitaxel promising for treating stomach cancer with peritoneal carcinomatosis?Yes, the drug combination of Fluorouracil, Leucovorin, and Paclitaxel shows promise for treating stomach cancer with peritoneal carcinomatosis. It is considered feasible for patients who cannot tolerate standard treatments, and it may help reduce the risk of cancer spreading in the abdomen.14689
What safety data exists for chemotherapy treatment of stomach cancer with peritoneal carcinomatosis?Several studies have evaluated the safety of chemotherapy treatments involving 5-fluorouracil (5-FU), leucovorin, and paclitaxel for advanced gastric cancer, including those with peritoneal carcinomatosis. These studies generally indicate that the combination of these drugs is effective and has a manageable safety profile. Specific studies include a Phase II study of bolus 5-FU and leucovorin with weekly paclitaxel, which assessed safety and efficacy, and a randomized Phase II/III study comparing 5-FU/l-leucovorin with and without paclitaxel, which also evaluated adverse effects. Another study focused on the combination of intravenous and intraperitoneal chemotherapy, identifying clinical and adverse effects. Overall, these studies suggest that the treatment is safe with known toxicities that are considered manageable.2371112
What data supports the idea that Chemotherapy for Stomach Cancer with Peritoneal Carcinomatosis is an effective treatment?The available research shows that the combination of 5-fluorouracil, leucovorin, and paclitaxel (FLTAX) has promising activity for patients with severe peritoneal metastases of gastric cancer. Although the combination did not show superiority in overall survival compared to 5-fluorouracil and leucovorin alone, it is considered feasible for patients who cannot tolerate standard treatments. Additionally, paclitaxel, when used with carboplatin, has shown effectiveness in achieving complete remission in some cases of peritoneal carcinomatosis, suggesting its potential benefit in certain patient groups.59101213
Do I need to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial investigators for guidance.
Eligibility Criteria
Adults aged 18-75 with gastric or gastroesophageal junction cancer and peritoneal carcinomatosis, who've had at least three months of initial treatment without visceral metastasis. Participants need good organ function, no severe heart conditions, infections, or other cancers in the last 3 years. Pregnant women are excluded and contraception is required during the trial.Inclusion Criteria
My cancer has spread to the lining of my abdomen.
My ability to perform daily activities is limited due to my cancer, not other illnesses.
I am between 18 and 75 years old.
Exclusion Criteria
My cancer has spread to distant organs like the liver, lungs, or brain.
I currently have an infection.
I've had surgery that makes it unsafe to do certain diagnostic procedures.
My cancer has spread to lymph nodes in my abdomen and cannot be surgically removed.
I am currently being treated for an infection.
I have symptoms of heart failure.
I have an irregular heartbeat.
I have an active tuberculosis infection.
I have unstable chest pain.
I have not had a stroke, heart attack, or similar event in the last 3 months.
Treatment Details
The trial tests a combination of systemic chemotherapy (Leucovorin, Fluorouracil) followed by intraperitoneal Paclitaxel to see if it's safe and works for patients with stomach cancer that has spread to the lining of their abdomen.
1Treatment groups
Experimental Treatment
Group I: SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal CarcinomatosisExperimental Treatment3 Interventions
Patients will receive sequential intraperitoneal paclitaxel along with intravenous paclitaxel, 5-FU, and leucovorin on Days 1 and 8 of every 21 day cycle for 3 months.
Fluorouracil is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Skin cancer
🇪🇺 Approved in European Union as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
🇨🇦 Approved in Canada as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, CA
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
References
Peritoneal carcinomatosis from adenocarcinoma of the colon. [2019]Peritoneal carcinomatosis is a major cause of surgical treatment failure in patients with colorectal cancer. In the past patients with this condition have had a lethal outcome. In this study, 64 consecutive patients were treated by the cytoreductive approach, which involved surgery to maximally resect all cancer in the abdomen and pelvis, early postoperative intraperitoneal chemotherapy with 5-fluorouracil (5-FU) and mitomycin C, and three cycles of adjuvant intraperitoneal 5-FU with systemic mitomycin C. The clinical features that may affect prognosis were assessed and critically analyzed statistically. Peritoneal implant size of
[Preliminary report of semimonthly 5-fluorouracil/leucovorin combined with paclitaxel in treatment of advanced gastric cancer (AGC)]. [2015]Phase II clinical trails showed that paclitaxel is effective in treatment of advanced gastric cancer (AGC). The combination of paclitaxel and 5-fluorouracil (5-FU) in the treatment of advanced gastric cancer is effective and safe. This study was designed to evaluate the efficacy and the toxicity of paclitaxel combined with semimonthly 5-FU/Leucovorin for the AGC patients.
A combination phase I study of weekly paclitaxel and doxifluridine in advanced gastric cancer patients. [2015]Preclinical studies have shown that paclitaxel and doxifluridine can act synergistically without overlapping toxicity for the treatment of advanced gastric cancer. The objectives of this study were to determine the maximum tolerated dose (MTD), the dose-limiting toxicity and the recommended Phase II dose for this drug combination.
Intraperitoneal paclitaxel: a possible impact of regional delivery for prevention of peritoneal carcinomatosis in patients with gastric carcinoma. [2015]Peritoneal carcinomatosis is a common pattern of failure among gastric cancer patients. Adequate postoperative adjuvant chemotherapy could reduce the risk of this lethal recurrence.
Paclitaxel and carboplatin-induced complete remission in peritoneal carcinomatosis of unknown origin: a report of two cases and review of the literature. [2022]Peritoneal carcinomatosis is a common evolution of digestive-tract cancer with a poor prognosis. However, a small subgroup unrelated to the digestive tract or any other primary cancer has a relatively better prognosis, especially in women. There are no published data to recommend a treatment regimen for this distinct group. Here we present two women with peritoneal carcinomatosis of unknown origin, who responded to chemotherapy with paclitaxel plus carboplatin. One underwent an exploratory laparotomy and was confirmed to have no residual tumor. The other had complete resolution of ascites and omentum lesions confirmed by radiological examination. From this experience we propose that paclitaxel plus carboplatin is an effective combination regimen for this unique subset of patients. Further prospective trials should be conducted to substantiate this proposal in a larger patient cohort.
Intraperitoneal docetaxel combined with S-1 for advanced gastric cancer with peritoneal dissemination. [2022]Our previous phase I study indicated that combination chemotherapy with intraperitoneal docetaxel and S-1 was well tolerated by gastric cancer patients with peritoneal carcinomatosis (PC). This study evaluated the benefits of this combination chemotherapy and subsequent surgery.
Phase II study of bolus 5-fluorouracil and leucovorin combined with weekly paclitaxel as first-line therapy for advanced gastric cancer. [2015]We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients.
A Phase II Study of Modified FOLFOX4 for Colorectal Cancer Patients with Peritoneal Carcinomatosis. [2021]Peritoneal carcinomatosis (PC) of colorectal cancer (CRC) is common and is the second most common cause of death. Clinical studies regarding chemotherapy for CRC with PC have been classically rather limited in scope. We evaluated the efficacy of modified oxaliplatin, leucovorin, and fluorouracil (m-FOLFOX4) regimen for PC of CRC origin.
Multicenter feasibility study of combination therapy with fluorouracil, leucovorin and paclitaxel (FLTAX) for peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake. [2022]Oral fluoropyrimidine plus cisplatin is a standard treatment for advanced gastric cancer, but patients with severe peritoneal metastasis often cannot tolerate this regimen. The aim of this study was to assess the feasibility of fluorouracil, l-leucovorin and paclitaxel therapy in such patients.
Randomized phase II study of second-line chemotherapy with the best available 5-fluorouracil regimen versus weekly administration of paclitaxel in far advanced gastric cancer with severe peritoneal metastases refractory to 5-fluorouracil-containing regimens (JCOG0407). [2022]This randomized phase II study compared weekly administration of paclitaxel (wPTX) with the best available 5-fluorouracil (5-FU) regimen as second-line treatment for advanced gastric cancer patients with severe peritoneal metastasis refractory to fluoropyrimidine.
Clinical Efficacy of Combination Intravenous and Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer with Peritoneal Carcinomatosis. [2019]To identify the clinical and adverse effects of intravenous chemotherapy combined with intraperitoneal chemotherapy in the treatment of gastric cancer with abdominal peritoneal carcinomatosis.
Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G). [2021]Oral fluoropyrimidine plus cisplatin is often not tolerated by patients with severe peritoneal metastases of gastric cancer. Combination of 5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX) has promising activity for such patients. We conducted a phase II/III study comparing FLTAX with 5-FU/l-LV.
Clinical implications of using both fluoropyrimidine and paclitaxel in patients with severe peritoneal metastasis of gastric cancer: A post hoc study of JCOG1108/WJOG7312G. [2022]In the JCOG1108/WJOG7312G trial, a combination (FLTAX) of 5-fluorouracil (FU) /leucovorin (FL) and paclitaxel (PTX) did not show superiority in overall survival (OS) to FL in untreated patients with severe peritoneal metastasis of gastric cancer (GC-SPM), some of whom received second-line chemotherapy with PTX after FL. This post hoc study aimed to investigate the clinical implications of using both FU and PTX either sequentially or in combination for patients with GC-SPM.