# Gemcitabine, cisplatin and nab-paclitaxel phase 2 (MD Anderson and Mayo)

Source: https://onco.cc/trials/gap-phase2-mdacc/  
OnCo record `gap-phase2-mdacc` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The 60-patient study that made the chemotherapy triplet look promising in bile duct and gallbladder cancer: nearly half responded and median survival was 19 months, results that the larger S1815 trial later failed to confirm.

## Summary

This open-label single-arm phase 2 (NCT02392637) at MD Anderson and Mayo Clinic Arizona enrolled 62 patients with advanced biliary tract cancer between 2015 and 2017; of 60 treated, 63 percent had intrahepatic cholangiocarcinoma, 15 percent extrahepatic and 22 percent gallbladder cancer, and 78 percent had metastatic disease. Starting doses of gemcitabine 1,000, cisplatin 25 and nab-paclitaxel 125 mg/m² on days 1 and 8 of 21-day cycles were reduced to 800, 25 and 100 mg/m² after haematological toxicity in the first 32 patients. Median progression-free survival, the primary endpoint, was 11.8 months (95 percent confidence interval 6.0 to 15.6), the partial response rate 45 percent, disease control 84 percent and median overall survival 19.2 months. The figures compared favourably with the 8.0 and 11.7 months of gemcitabine and cisplatin in ABC-02 and led directly to SWOG S1815, which found no survival benefit; the contrast is a reminder that single-arm phase 2 results in selected academic-centre populations overestimate effects.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Also known as: GAP phase 2
- Tags: lesson:single-arm-phase-2
- Registry id: NCT02392637
- Phase: 2
- Setting: Advanced biliary tract cancer, first line: gemcitabine, cisplatin and nab-paclitaxel, single arm
- Sponsor: M.D. Anderson Cancer Center
- Enrolled: 62
- Result: Median PFS 11.8 months; partial response 45%; median OS 19.2 months (single arm).
- Outcomes: Progression-free survival: Gemcitabine + cisplatin + nab-paclitaxel 11.8 months; Overall survival: Gemcitabine + cisplatin + nab-paclitaxel 19.2 months

## Sources

- ClinicalTrials.gov NCT02392637: https://clinicaltrials.gov/study/NCT02392637
- Shroff et al., JAMA Oncology 2019: https://doi.org/10.1001/jamaoncol.2019.0270

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/)
- institutions: [Mayo Clinic](https://onco.cc/institutions/mayo-clinic/), [MD Anderson Cancer Center](https://onco.cc/institutions/md-anderson/)
- key papers: [Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial](https://onco.cc/key-papers/paper-gap-phase2-mdacc-jama-oncol-2019/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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