Evidence map›Paper›PMID 18414865›Full record

ArticleCancer chemotherapy and pharmacology2009

Phase I clinical and pharmacokinetic study of oxaliplatin, irinotecan and capecitabine.

Smitha S Krishnamurthi, Joanna M Brell, Charles L Hoppel, Merrill J Egorin, Karen C Weaver, Xiaolin Li, Stephen T Ingalls, Eleanor G Zuhowski, Mark D Schluchter, Afshin Dowlati and 5 more

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

Article in Cancer chemotherapy and pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006465 (Phase I Study of Oxaliplatin), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT00006465 phase1completednot on this map

Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors

TypeinterventionalSponsorCase Comprehensive Cancer CenterRan2000 to 2005Enrolled22ConditionsUnspecified Adult Solid Tumor, Protocol SpecificArmscapecitabine, irinotecan hydrochloride, oxaliplatin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Phase I Clinical Trials in Patients ≥80.Journal of geriatric oncology · 2011
    Article
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

15 authors at 5 institutions in 1 country.

Smitha S KrishnamurthiDevelopmental Therapeutics Program, Case Comprehensive Cancer Center, Cleveland, OH, USA. ssk7@case.edu
Joanna M Brell
Charles L Hoppel
Merrill J Egorin
Karen C Weaver
Xiaolin Li
Stephen T Ingalls
Eleanor G Zuhowski
Mark D Schluchter
Afshin Dowlati
Matthew M Cooney
Joseph Gibbons
Beth A Overmoyer
S Percy Ivy
Scot C Remick
Case Comprehensive Cancer CenterComprehensive Clinical Research · USUniversity Hospitals Case Medical Center · USUPMC Hillman Cancer Center · USNational Cancer Institute · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Leonard J. Appleman · 1988 to 2026
$158.0M
TUMOR METABOLISM PROGRAMP30CA043703 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Drew James Adams · 1987 to 2026
$142.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
Zosuquidar trihydrochloride for acute myeloid leukemia &refractory anemiaM01RR000080 · NCRR · UNIVERSITY HOSPITALS OF CLEVELAND · PI DAVIS, PAMELA B · 1985 to 2007
$22.2M
TRANSLATIONAL RESEARCH ONCOLOGY TRAINING GRANTK12CA076917 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERSON, STANTON L. · 1997 to 2022
$14.2M
Early Clinical Trials of New Anti-Cancer Agents with Phase I EmphasisU01CA062502 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI DOWLATI, AFSHIN · 1994 to 2013
$9.3M
Phase I Clinical Trials of Novel Anticancer AgentsU01CA099168 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CHU, EDWARD · 2003 to 2013
$5.0M
NCI NIH HHS K12 CA076917NCI NIH HHS K12 CA76917NCI NIH HHS P30 CA043703NCI NIH HHS P30 CA047904NCI NIH HHS P30 CA43703NCI NIH HHS P30CA47904NCI NIH HHS U01 CA062502NCI NIH HHS U01 CA099168NCI NIH HHS U01-CA099168-01NCI NIH HHS U01 CA62502NCRR NIH HHS M01 RR000080NCRR NIH HHS M01-RR-00080
6 · The paper itself

Abstract

purposeTo determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of the combination of weekly oxaliplatin x 4, weekly irinotecan x 4 and capecitabine Monday through Friday for 4 weeks of every 6 week cycle in patients with solid tumors; to determine the pharmacokinetic profile of these agents in this combination; to observe patients for clinical anti-tumor response.

methodsTwenty-two patients with metastatic solid tumors received oxaliplatin 60 mg/m(2) weekly x 4, irinotecan beginning at a dose of 40 mg/m(2) weekly x 4, and capecitabine Monday through Friday for 4 weeks of every 6 week cycle, initially at 1,000 mg twice daily (bid).

resultsThe MTD was oxaliplatin 60 mg/m(2) weekly x 4, irinotecan 50 mg/m(2) weekly x 4 and capecitabine 450 mg bid Monday through Friday for 4 weeks of every 6 week cycle. One of six patients at this dose level developed DLT of nausea, vomiting, and diarrhea. Among patients treated with a constant capecitabine dose of 450 mg bid, there was a higher mean AUC of 5-FU in women than in men (mean +/- SD: 892 +/- 287 nM h vs. 537 +/- 182 nM h; Mann-Whitney two-tailed, P = 0.02). There was one complete response in a patient with gastric cancer.

conclusionThe novel schedule of weekly oxaliplatin, weekly irinotecan, and capecitabine Monday through Friday, all administered for 4 weeks of every 6 week cycle, evaluated in this phase I trial is well-tolerated and demonstrated activity in a patient with gastric cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCamptothecinCapecitabineDeoxycytidineFemaleFluorouracilHumansIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsOrganoplatinum CompoundsCamptothecinCapecitabineDeoxycytidineFluorouracilIrinotecanOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID18414865
PMCPMC4788493
OpenAlexW2142476983

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.