Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05977998
Other study ID # 2023-0331
Secondary ID NCI-2023-05915
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 8, 2023
Est. completion date October 31, 2030

Study information

Verified date June 2024
Source M.D. Anderson Cancer Center
Contact Hsiu-Yin Chang, RN
Phone 713-745-7335
Email hchang@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.


Description:

Primary Objectives: To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative intraperitoneal paclitaxel and gastrectomy. Secondary Objectives: To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis undergoing treatment with perioperative intraperitoneal paclitaxel.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 31, 2030
Est. primary completion date October 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients <18 years of age, children are excluded from this study. 2. ECOG performance status = 2 (Karnofsky =60%). Appendices 1 and 2. 3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction. 4. Adequate renal, and bone marrow function: 1. Leukocytes >= 3,000/uL 2. Absolute neutrophil count >= 1,500/uL 3. Platelets >= 60,000/Ul 4. Serum creatinine <= 1.6 mg/dL 5. Distant Metastatic Disease of peritoneum: 1. Positive peritoneal cytology, or 2. Carcinomatosis on diagnostic laparoscopy or laparotomy. 6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued. 7. English and non-English speaking patients are eligible. Exclusion Criteria: 1. Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung. 2. Infections such as pneumonia or wound infections that would preclude protocol therapy. 3. 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-oophorectomy, 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). 4. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure. 5. Subjects, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures. 6. 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. 7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.

Study Design


Intervention

Drug:
Paclitaxel
Given by IP (Intraperitoneal injection)
Dexamethasone
Given by IV (vein)
Diphenhydramine
Given by IV (vein)
Famotidine
Given by IV (vein)

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 through study completion; an average 1 year.
See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT03257163 - Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01178944 - Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer Phase 2
Terminated NCT00209079 - Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma Phase 2
Terminated NCT02862535 - Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma Phase 1
Active, not recruiting NCT05008783 - A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Completed NCT03196232 - Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Phase 2
Recruiting NCT04047953 - Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma N/A
Completed NCT02864381 - Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2
Terminated NCT04604132 - Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Phase 1/Phase 2
Completed NCT02830594 - Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer Phase 2
Recruiting NCT06038578 - A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer Phase 2
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Recruiting NCT04581473 - Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection Phase 1/Phase 2

External Links