OncoMatch/Clinical Trials/NCT04115163
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
Is NCT04115163 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Nab-paclitaxel for metastatic pancreatic adenocarcinoma.
Treatment: Gemcitabine · Nab-paclitaxel — This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
KARNOFSKY OR ECOG 0–2
Karnofsky performance status (KPS) >= 60 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Prior therapy
Cannot have received: chemotherapy
Exception: Prior adjuvant treatment allowed if last chemotherapy > 6 months ago; prior 5-fluorouracil (5-FU) or gemcitabine as radiation sensitizer or in adjuvant setting allowed if at least 2 months since last dose and no lingering significant toxicities
no previous chemotherapy or investigational therapy for the treatment of metastatic pancreatic cancer. Prior adjuvant treatment is allowed as long as the last chemotherapy was > 6 months ago. Prior use of 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer or in the adjuvant setting is allowed, provided at least 2 month have elapsed since completion of the last dose and no lingering significant toxicities are present.
Lab requirements
Blood counts
ANC >= 1.5 x 10^9/L; Platelet count >= 100,000/mm^3 (100 x 10^9/L); Hemoglobin >= 9 g/dL
Liver function
AST/ALT <= 2.5 x ULN, unless liver metastases are clearly present, then <= 5 x ULN; total bilirubin <= 2 x ULN
ANC >= 1.5 x 10^9/L ... Platelet count >= 100,000/mm^3 ... Hemoglobin (Hgb) >= 9 g/dL ... AST/ALT <= 2.5 x ULN, unless liver metastases are clearly present, then <= 5 x ULN ... Total bilirubin <= 2 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify