Evidence map›Paper›PMID 19738454›Full record

ArticleAmerican journal of clinical oncology2010

A phase I trial of oblimersen sodium in combination with cisplatin and 5-fluorouracil in patients with advanced esophageal, gastroesophageal junction, and gastric carcinoma.

Rachel Raab, Joseph A Sparano, Allyson J Ocean, Paul Christos, Mark Ramirez, Vincent Vinciguerra, Andreas Kaubisch

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in American journal of clinical oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00064259 (A Phase I/II Study of Oblimersen in Combination With Cisplatin and Fluorouracil in Patients With Advanced Esophageal, Gastro-Esophageal Junction and Gastric Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

NCT00064259 phase1 / phase2terminatednot on this map

A Phase I/II Study of Oblimersen in Combination With Cisplatin and Fluorouracil in Patients With Advanced Esophageal, Gastro-Esophageal Junction and Gastric Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2003 to 2010Enrolled15ConditionsAdenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the StomachArmsoblimersen sodium, cisplatin, fluorouracil
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Rachel RaabDepartment of Oncology, Montefiore-Einstein Cancer Center, New York Cancer Consortium Coordinating Center, Bronx, New York 10461, USA.
Joseph A Sparano
Allyson J Ocean
Paul Christos
Mark Ramirez
Vincent Vinciguerra
Andreas Kaubisch
Albert Einstein College of Medicine · USNewYork–Presbyterian Hospital · USMontefiore Einstein Comprehensive Cancer CenterNorth Shore University Hospital · US

Funding

NCI NIH HHS N01 CM017103NCI NIH HHS N01 CM062204NCI NIH HHS N01-CM-62204
6 · The paper itself

Abstract

purposeTo determine the maximum tolerated dose of oblimersen, an antisense oligonucleotide directed to the Bcl-2 mRNA, in combination with cisplatin and 5-flourouracil in patients with advanced gastric and esophageal carcinoma.

methodsPatients were treated with escalating doses of oblimersen administered by continuous intravenous infusion (CIVI) days 1 to 7, CIVI 5-fluorouracil (5-FU) days 4 to 7, and cisplatin on day 4 every 3 weeks.

resultsFifteen patients received a total of 49 courses of oblimersen at doses of 3, 5, or 7 mg/kg/d given as a 7 day CIVI in combination with 4 or 5 day CIVI of 5-FU (1000 or 750 mg/m2/d) plus intravenous cisplatin (100 or 75 mg/m2 over 2 hours). The recommended phase II dose of oblimersen was 5 mg/kg/d in combination with 5-FU (750 mg/m2/d for 4 days) and cisplatin (75 mg/m). The most common grade 3 to 4 adverse events that occurred in at least 10% of patients at all dose levels included neutropenia (33%), hypokalemia (27%), infection (20%), and mucositis, fatigue, dizziness, thrombosis, and dehydration (in 13% for each category).

conclusionThe combination of oblimersen with 5-FU and cisplatin chemotherapy is feasible in patients with advanced upper gastrointestinal cancer, with antitumor activity observed in gastric carcinoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinDrug Therapy, CombinationEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingOligonucleotides, AntisensePilot ProjectsCisplatinFluorouraciloblimersenOligonucleotides, AntisenseThionucleotides

Identifiers

PMID19738454
PMCPMC3555559
OpenAlexW1967482611

What OpenQuestion holds

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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.