Phase 2
Completed N=39
Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
Source: ClinicalTrials.gov NCT00536874 ↗Enrolled (actual)
39
Serious AEs
64.1%
Results posted
Dec 2015
Primary outcomePrimary: Overall Survival at 18 Months — 63 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 18 Months |
63 | — |
| SECONDARY Overall Survival (Follow-Up Time) |
39.6 | — |
| SECONDARY Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy |
-5.1 | — |
| SECONDARY RECIST Radiologic Response to Neoadjuvant Therapy |
4; 28; 3; 3 | — |
| SECONDARY Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy |
-25.6 | — |
Eligibility Criteria
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 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, allowed
Data sourced from ClinicalTrials.gov (NCT00536874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.