Evidence map›Paper›PMID 19434371›Full record

ArticleInvestigational new drugs2010

Phase I trial of weekly docetaxel, weekly doxorubicin, daily oral cyclophosphamide, and G-CSF (ConTAC regimen) in advanced malignancies.

Robert Wesolowski, David Peereboom, Patricia Weiss, Paul Elson, George Thomas Budd

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 45% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Current state and future opportunities in granulocyte colony-stimulating factor (G-CSF).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  2. 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

5 authors at 2 institutions in 2 countries.

Robert WesolowskiCleveland Clinic, Taussig Cancer Institute, R35, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
David Peereboom
Patricia Weiss
Paul Elson
George Thomas Budd
Cancer Institute (WIA) · INCleveland Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis was a phase I study evaluating the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of weekly docetaxel, doxorubicin and daily oral cyclophosphamide with G-CSF support (ConTAC regimen). PATIENTS AND

methodsCohorts of 3-6 patients with advanced breast or other solid malignancies were entered at subsequently higher dose levels until dose-limiting toxicities (DLT) were noted in 2 or more patients per dose level during the first 6 weeks of therapy. This study escalated dosages of docetaxel and doxorubicin simultaneously, while the dose of oral cyclophosphamide was fixed at 60 mg/m(2) daily.

resultsSixteen patients were enrolled. Grade 3-4 adverse events during the first 6 weeks of treatment were neutropenia (n = 1 at dose level #1 and n = 3 at dose level #4), anemia (n = 2 at dose levels 1 and 4), and nausea/vomiting (n = 1 at dose level #4). After 6 weeks of therapy, grade 3-4 toxicities included anemia (n = 3), neutropenia (n = 7), Hand-Foot syndrome (n = 2) and grade 3 cystitis and pneumonia (n = 1 at dose level #4). Five patients with advanced breast cancer and 1 patient with metastatic lung cancer responded to the chemotherapy.

conclusionsGrade 4 neutropenia was the DLT. The MTD, was established at dose level #3 (doxorubicin at 25 mg/m(2) and docetaxel at 25 mg/m(2) weekly with oral cyclophosphamide dose of 60 mg/m(2) daily). Myelosuppression at that dose level was moderate with G-CSF given concurrently.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDocetaxelDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFemaleGranulocyte Colony-Stimulating FactorHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsCyclophosphamideDocetaxelDoxorubicinGranulocyte Colony-Stimulating FactorTaxoids

Identifiers

PMID19434371
OpenAlexW2063272107

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.