Clinical trial · Interventional
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
NCT03535727CI-TRIAL-00084207completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Digestive System Disease | — | UNRESOLVED | — |
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endocrine Gland Neoplasms | — | UNRESOLVED | — |
| Endocrine System Diseases | — | UNRESOLVED | — |
| Neoplasm, Glandular | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms Pancreatic | — | UNRESOLVED | — |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Phase 1, Cohort 1, Dose level 1
- description
- Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel: 40 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
- interventionNames
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
- Drug: Capecitabine
- Drug: Cisplatin
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Phase 1, Cohort 1, Dose level 2
- description
- Gemcitabine 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel 60 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. * Patients with the presence of at least one measurable lesion. * Male or non-pregnant and non-lactating female of age \>18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients who will be considered for surgery are ineligible. * Patient who have had any prior chemotherapy within 5 years of enrollment. * Patient who have had radiotherapy for pancreatic cancer. * Age ≥ 76 years * Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study. * Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study. * Patient who has known brain metastases. * Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan. * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patient who has serious medical risk factors involving any of the major organ systems. * Patient who has known history of infection with HIV, hepatitis B, or hepatitis C. * Pregnant or breast feeding. * Patient is unwilling or unable to comply with study procedures * Patient with clinically significant wound.
References
Publications (0)
Data not yet available
No reference posted for this study.