Gastric Adenocarcinoma Clinical Trial
Official title:
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
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. |
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 |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
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 | |
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 |