Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011
Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 11 registered trials, which are not on this map. Cited by 516 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer
A Randomized Phase II Open Label Study to Assess the Efficacy & Safety of Gemcitabine + Abraxane® With or Without ODSH (2-0, 3-0 Desulfated Heparin) as First Line Treatment of Metastatic Pancreatic Cancer
A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer
A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2 O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
A Phase 1B Study to Determine the Safety and Tolerability and Confirm the Dose of Canakinumab and Spartalizumab in Combination With Nab-paclitaxel and Gemcitabine for Patients With Metastatic Pancreatic Cancer
A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients With Advanced Solid Tumors
An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer
Clinical Efficacy of QingyiHuaji Optimized Formula Combined With Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Study
Who cites it
516 citing papers in PubMed, 2 syntheses or guidelines pooled it, 1,042 citations in OpenAlex.
- Research advances and treatment perspectives of pancreatic adenosquamous carcinoma.Cellular oncology (Dordrecht, Netherlands) · 2023Pooled it
- Efficacy and safety of nab-paclitaxel plus platinum in non-small cell lung cancer: a meta-analysis.Frontiers in medicine · 2023Pooled it
- Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial.Japanese journal of clinical oncology · 2023Trial
- Diffusion-weighted MRI predicts the histologic response for neoadjuvant therapy in patients with pancreatic cancer: a prospective study (DIFFERENT trial).Langenbeck's archives of surgery · 2020Trial
- Trial
- Phase I/II Study: Experience with the Late Onset of Acute Pancreatitis after the Start of Chemotherapy with Gemcitabine Plus nab-Paclitaxel for Metastatic Pancreatic Cancer.Internal medicine (Tokyo, Japan) · 2019Trial
- Effect of Gemcitabine and nab-Paclitaxel With or Without Hydroxychloroquine on Patients With Advanced Pancreatic Cancer: A Phase 2 Randomized Clinical Trial.JAMA oncology · 2019Trial
- Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial.JAMA oncology · 2019Trial
- The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer.Cancer communications (London, England) · 2019Trial
- Outcomes of Irreversible Electroporation for Treatment of Refractory Locally Advanced Pancreatic Cancer.Journal of vascular and interventional radiology : JVIR · 2026Article
- Efficacy and Safety of First-Line Chemotherapy With Gemcitabine Plus Nab-Paclitaxel in Unresectable Gallbladder Cancer.Cancer medicine · 2026Article
- Outcomes of conversion surgery for patients with locally advanced pancreatic cancer under strict indication criteria.Surgery today · 2026Article
- Albumin-based nanocarriers: Singularities, synthesis methods, clinical relevance and targeting strategies in cancer.Acta pharmaceutica Sinica. B · 2026Review
- Sensitising PDAC to Gemcitabine by Suppressing NF-κB Pathway and Enhancing Apoptosis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Current Advances in Preclinical Patient-Derived Cultivation Models for Individualized Drug Response Prediction in Pancreatic Cancer.Oncology research · 2026Review
- Controlled Self-Immolative Release of β-Lapachone via an OptimizedJournal of the American Chemical Society · 2025Article
- Immune cell changes following chemotherapy in advanced pancreatic cancer with variations based on gender.Scientific reports · 2025Article
- Pancreatic cancer in 2025: Have we found a solution?World journal of gastroenterology · 2025Review
- Stromal secreted protein acidic and rich in cysteine expression: A potential target for improved prognosis in patients with pancreatic cancer.World journal of gastrointestinal oncology · 2025Article
- Factors associated with taxane-associated acute pain syndrome in pancreatic cancer patients receiving gemcitabine and nab-paclitaxel.Discover oncology · 2025Article
456 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 1 institution in 1 country.
Funding
Abstract
purposeThe trial objectives were to identify the maximum-tolerated dose (MTD) of first-line gemcitabine plus nab-paclitaxel in metastatic pancreatic adenocarcinoma and to provide efficacy and safety data. Additional objectives were to evaluate positron emission tomography (PET) scan response, secreted protein acidic and rich in cysteine (SPARC), and CA19-9 levels in relation to efficacy. Subsequent preclinical studies investigated the changes involving the pancreatic stroma and drug uptake. PATIENTS AND
methodsPatients with previously untreated advanced pancreatic cancer were treated with 100, 125, or 150 mg/m(2) nab-paclitaxel followed by gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 every 28 days. In the preclinical study, mice were implanted with human pancreatic cancers and treated with study agents.
resultsA total of 20, 44, and three patients received nab-paclitaxel at 100, 125, and 150 mg/m(2), respectively. The MTD was 1,000 mg/m(2) of gemcitabine plus 125 mg/m(2) of nab-paclitaxel once a week for 3 weeks, every 28 days. Dose-limiting toxicities were sepsis and neutropenia. At the MTD, the response rate was 48%, with 12.2 median months of overall survival (OS) and 48% 1-year survival. Improved OS was observed in patients who had a complete metabolic response on [(18)F]fluorodeoxyglucose PET. Decreases in CA19-9 levels were correlated with increased response rate, progression-free survival, and OS. SPARC in the stroma, but not in the tumor, was correlated with improved survival. In mice with human pancreatic cancer xenografts, nab-paclitaxel alone and in combination with gemcitabine depleted the desmoplastic stroma. The intratumoral concentration of gemcitabine was increased by 2.8-fold in mice receiving nab-paclitaxel plus gemcitabine versus those receiving gemcitabine alone.
conclusionThe regimen of nab-paclitaxel plus gemcitabine has tolerable adverse effects with substantial antitumor activity, warranting phase III evaluation.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.