Evidence map›Paper›PMID 19858396›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904.

Matthew H Kulke, Margaret A Tempero, Donna Niedzwiecki, Donna R Hollis, Hedy L Kindler, Michael Cusnir, Peter C Enzinger, Stefan M Gorsch, Richard M Goldberg, Robert J Mayer

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00012220 (A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer), which is not on this map. Cited by 36 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 11 pooled it
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT00012220 phase2completednot on this map

A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2001 to 2009Enrolled259ConditionsPancreatic CancerArmscisplatin, docetaxel, gemcitabine hydrochloride, irinotecan hydrochloride
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 11 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pancreatic adenocarcinoma.Journal of the National Comprehensive Cancer Network : JNCCN · 2010
    Guideline
  10. Pooled it
  11. Pooled it
  12. A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2015
    Trial
  13. Trial
  14. Efficacy and safety of gemcitabine plus S-1Cancer biology & medicine · 2023
    Article
  15. Article
  16. Article
  17. Review
  18. Anticancer Activity of Natural Compounds from Plant and Marine Environment.International journal of molecular sciences · 2018
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Matthew H KulkeDana-Farber Cancer Institute, Boston, MA, USA. matthew_kulke@dfci.harvard.edu
Margaret A Tempero
Donna Niedzwiecki
Donna R Hollis
Hedy L Kindler
Michael Cusnir
Peter C Enzinger
Stefan M Gorsch
Richard M Goldberg
Robert J Mayer
Sylvester Comprehensive Cancer Center · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601
6 · The paper itself

Abstract

purposeThe relative value of gemcitabine-based combination chemotherapy therapy and prolonged infusions of gemcitabine in patients with advanced pancreatic cancer remains controversial. We explored the efficacy and toxicity of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in a multi-institutional, randomized, phase II study. PATIENTS AND

methodsPatients with metastatic pancreatic cancer were randomly assigned to one of the following four regimens: gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 with cisplatin 50 mg/m(2) on days 1 and 15 (arm A); gemcitabine 1,500 mg/m(2) at a rate of 10 mg/m(2)/min on days 1, 8, and 15 (arm B); gemcitabine 1,000 mg/m(2) with docetaxel 40 mg/m(2) on days 1 and 8 (arm C); or gemcitabine 1,000 mg/m(2) with irinotecan 100 mg/m(2) on days 1 and 8 (arm D). Patients were observed for response, toxicity, and survival. Results Two hundred fifty-nine patients were enrolled onto the study, of whom 245 were eligible and received treatment. Anticipated rates of myelosuppression, fatigue, and expected regimen-specific toxicities were observed. The overall tumor response rates were 12% to 14%, and the median overall survival times were 6.4 to 7.1 months among the four regimens.

conclusionGemcitabine/cisplatin, fixed dose rate gemcitabine, gemcitabine/docetaxel, and gemcitabine/irinotecan have similar antitumor activity in metastatic pancreatic cancer. In light of recent negative randomized studies directly comparing several of these regimens with standard gemcitabine, none of these approaches can be recommended for routine use in patients with this disease.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCisplatinConfidence IntervalsDeoxycytidineDocetaxelDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesGemcitabineHumansCamptothecinCisplatinDeoxycytidineDocetaxelGemcitabineIrinotecanTaxoids

Identifiers

PMID19858396
PMCPMC2792952
OpenAlexW2164192604

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.