Clinical trial · Interventional
Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
- 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)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| protein expression analysis | Genetic | — | UNRESOLVED |
| proteomic profiling | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine And Oxaliplatin
- description
- A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: oxaliplatin
- Genetic: protein expression analysis
- Genetic: proteomic profiling
- Other: diagnostic laboratory biomarker analysis
- Procedure: adjuvant therapy
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Overall Survival at 18 Months
- timeFrame
- 18 months
- description
- Percentage of participants that were alive or survived at 18 months after randomization
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar cancer)
* Patients with adenosquamous variants are eligible
* Radiographically resectable pancreatic cancer, as determined by a surgical oncologist
* No metastatic or locally unresectable pancreatic adenocarcinoma
* No evidence of distant metastases by CT scan
* Negative or pending laparoscopy for distant metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 4.0 mg/dL (if \> 3.0, stented and known to be declining)
* Serum creatinine ≤ 1.6 mg/dL
* INR \< 1.5 (therapeutic INR is allowed for patients receiving therapeutic anticoagulation)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No active infection, except for resolving cholangitis, that would preclude study enrollment
* Neoadjuvant therapy may only be initiated when acute cholangitis has resolved
* No other malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or localized prostate cancer with a PSA of \< 5.0 ng/mL within ≥ 4 weeks of study entry (other circumstances with a recent concurrent or active malignancy will be adjudicated on a case-by-case basis by the principle investigator \[PI\] or co-PI)
* No known hypersensitivity to any of the components of oxaliplatin or gemcitabine
* No hypersensitivity to CT scan IV contrast dye not suitable for premedication
* No peripheral neuropathy ≥ grade 2
* No known HIV or hepatitis B or C infection (active, previously treated, or both)
* No other medical condition, including mental illness or substance abuse that, deemed by the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to \> 25% of bone marrow
* More than 30 days since prior and no other concurrent investigational therapy
* No other prior therapy for pancreatic cancer
* No other concurrent chemotherapy, immunotherapy, or radiotherapy during neoadjuvant therapy
* Concurrent low molecular weight heparin or warfarin, where medically indicated, allowedReferences
Publications (1)
- DERIVEDO'Reilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, D'Angelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251. PMID 24901360