Clinical trial · Interventional
Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) for Pancreatic Adenocarcinoma
A Phase I Study of Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
NCT01161186CI-TRIAL-00008248completedPhase 1ClinicalTrials.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 optimal dose and safety of the combination of Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with metastatic pancreatic cancer.
Conditions
Conditions (3)
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 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel, gemcitabine, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel,Gemcitabine, and Capecitabine
- interventionNames
- Drug: nab-paclitaxel, gemcitabine, capecitabine
Primary outcomes (1)
- measure
- to establish the maximal tolerated dose (MTD) of the AGX combination in patients with previously untreated, metastatic pancreatic adenocarcinoma.
- timeFrame
- Ongoing evaluation through sequential dose cohorts
Secondary outcomes (2)
- measure
- To assess the safety profile of this combination (AGX) using NCI-CTCAE v.4 criteria.
- timeFrame
- Ongoing evaluation for all patients throughout the course of treatment
- measure
- To obtain a preliminary assessment of the clinical efficacy of AGX as measured by time to tumor progression, overall survival, objective radiographic response (ORR), and CA 19-9 biomarker response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically-confirmed pancreatic adenocarcinoma 2. Stage IV disease (metastatic only) 3. No prior systemic therapy for their diagnosis (except in adjuvant setting \> six months previously) 4. ECOG performance score of 0-1 5. At least 18 years of age 6. Evidence of either or both of the following: * RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan) * An elevated serum CA19-9 at baseline ( ≥ 2X ULN) 7. Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator. 8. Adequate bone marrow function: * ANC ≥ 1500/uL * platelet count ≥ 100,000/uL * hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 X ULN * AST (SGOT) ≤ 2.5 X ULN * ALT (SGPT) ≤ 2.5 X ULN 10\. Adequate renal function as determined by either: * Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). The Modified Cockcroft-Gault formula is as follows: ((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl)) * Multiply by another factor of 0.85 if female * Serum creatinine ≤ 1.5 X ULN 11. Ability to swallow oral medications 12. Ability to understand the nature of this study protocol and give written informed consent 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed \> 6 months prior to the time of study enrollment. 2. Inability to comply with study and/or follow-up procedures. 3. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study. 4. Presence of central nervous system or brain metastases. 5. Life expectancy \< 12 weeks 6. Pregnancy (positive pregnancy test) or lactation. 7. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years. 8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. 9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. 10. Known, existing uncontrolled coagulopathy. 11. Pre-existing sensory neuropathy \> grade 1. 12. Major surgery within 4 weeks of the start of study treatment, without complete recovery. 13. Concurrent/pre-existing use of coumadin.
References
Publications (0)
Data not yet available
No reference posted for this study.