Evidence map›Paper›PMID 11742479›Full record

Trial reportBritish journal of cancer2001

A phase I and pharmacokinetic study of intraperitoneal topotecan.

L S Hofstra, A M Bos, E G de Vries, A G van der Zee, J H Beijnen, H Rosing, N H Mulder, J G Aalders, P H Willemse

Open access · hybridAbstract readClinical TrialClinical Trial, Phase I
In one paragraph

Trial report in British journal of cancer, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
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

9 authors at 2 institutions in 1 country.

L S HofstraDepartment of Medical, Gynaecologic Oncology, University Hospital Groningen, PO Box 30.001, Groningen, RB, 9700, The Netherlands.
A M Bos
E G de Vries
A G van der Zee
J H Beijnen
H Rosing
N H Mulder
J G Aalders
P H Willemse
University Medical Center Groningen · NLSlotervaartziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the feasibility and pharmacology of intraperitoneal (IP) topotecan. PATIENTS AND

methodsFifteen patients with recurrent ovarian cancer in a phase I trial were treated with escalating IP topotecan doses (5-30 mg/m(2)) for pharmacokinetic analysis.

resultsDose limiting toxicity (DLT) was acute hypotension, chills and fever at the 30 mg/m(2) dose level. Haematological toxicity and abdominal pain were mild for all dose levels studied. PHARMACOKINETICS: Peak plasma levels of total topotecan were reached at 2.7 +/- 1.1 h after IP instillation. The apparent V(ss) was 69.9 +/- 25.4 L/m(2), plasma clearance 13.4 +/- 2.5 L/h/m(2) and plasma T1/2 3.7 +/- 1.3 h. The plasma AUC was correlated with the dose (R = 0.95, P < 0.01). The plasma AUC ratio of lactone versus total topotecan (lactone + carboxy-forms) increased with the dose from 16% to 55%, (R = 0.84, P < 0.01). Peritoneal total topotecan was cleared from the peritoneal cavity at 0.4 +/- 0.3 L/h.m(2) with a T1/2 = 2.7 +/- 1.7 h. The mean peritoneal/plasma AUC ratio for total topotecan was 54 +/- 34.

conclusionA substantial dose of topotecan can be delivered by the IP route, achieving cytotoxic plasma levels of topotecan, with acceptable toxicity. The recommended dose for further phase II trials is 20 mg/m(2) IP, which enables combination with active doses of other cytotoxic drugs, in view of its limited myelotoxicity when given by this route.

Indexed as

AdultAgedAntineoplastic AgentsArea Under CurveDose-Response Relationship, DrugExanthemaFatigueFemaleHumansInjections, IntraperitonealMetabolic Clearance RateMiddle AgedNauseaOvarian NeoplasmsTopotecanTreatment OutcomeAntineoplastic AgentsTopotecan

Identifiers

PMID11742479
PMCPMC2363984
OpenAlexW1603447559

What OpenQuestion holds

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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.