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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05915 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental | Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given by IP (Intraperitoneal injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
Adequate renal, and bone marrow function:
Distant Metastatic Disease of peritoneum:
Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
English and non-English speaking patients are eligible.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iqra Rehman, RN | Contact | 713-535-0703 | IRehman1@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Badgwell, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2023 | Mar 4, 2025 |
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| Dexamethasone | Drug | Given by IV (vein) |
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| Diphenhydramine | Drug | Given by IV (vein) |
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| Famotidine | Drug | Given by IV (vein) |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D004155 | Diphenhydramine |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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