Evidence map›Paper›PMID 28595616›Full record

ArticleBMC cancer2017

Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers.

Hye Sook Chon, Sokbom Kang, Jae K Lee, Sachin M Apte, Mian M Shahzad, Irene Williams-Elson, Robert M Wenham

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

Article in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01256268 (Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT01256268 phase1completednot on this map

Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2011 to 2017Enrolled24ConditionsEndometrial Cancer, Ovarian CancerArmsRidaforolimus, Paclitaxel, carboplatin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Transcriptomic analysis revealsOncology letters · 2024
    Article
  4. Review
  5. Drug repositioningFrontiers in oncology · 2023
    Article
  6. Review
  7. Review
  8. New therapies for advanced, recurrent, and metastatic endometrial cancers.Gynecologic oncology research and practice · 2017
    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

7 authors at 2 institutions in 2 countries.

Hye Sook ChonDepartment of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA.
Sokbom KangDivision of Gynecologic Cancer Research, Center for Uterine Cancer, National Cancer Center, Ilsan-gu Madu-dong, Goyang, 410-768, Korea.
Jae K LeeDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA.
Sachin M ApteDepartment of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA.
Mian M ShahzadDepartment of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA.
Irene Williams-ElsonClinical Trials Office, Phase 1 Clinical trials, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA.
Robert M WenhamDepartment of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33647, USA. Robert.Wenham@moffitt.org.
Moffitt Cancer Center · USNational Cancer Center · KR

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundRidaforolimus is a mammalian target of rapamycin inhibitor that has activity in solid tumors. Paclitaxel and carboplatin have broad antineoplastic activity in many cancers. This phase I trial was conducted to determine the safety profile, maximal tolerated dose, and recommended phase II dose and schedule of oral ridaforolimus combined with paclitaxel and carboplatin in patients with solid tumor cancers.

methodsEligible patients with advanced solid tumor cancers received oral 10 to 30 mg ridaforolimus daily for 5 consecutive days per week combined with intravenous paclitaxel (175 mg/m

resultsThirty-one patients were consented, 28 patients were screened, and 24 patients met eligibility requirements and received treatment. Two patients were replaced for events unrelated to drug-related toxicity, resulting in 22 DLT-evaluable patients. Two grade 4 DLTs due to neutropenia were observed at dose level 1. The next cohort was changed to a predefined alternate dosing schedule (days 1-5 and 8-12). DLTs were neutropenia, sepsis, mucositis, and thrombocytopenia. The most common adverse events were neutropenia, anemia, thrombocytopenia, fatigue, alopecia, nausea, pain, and leukopenia. Twenty-four patients received a median of 4 cycles (range, 1-12). Evaluable patients for response (n = 18) demonstrated a median tumor measurement decrease of 25%. The best response in these 18 patients included 9 patients with partial response (50%), 6 with stable disease (33%), and 3 with progressive disease (17%). Thirteen of these patients received treatment for 4 or more cycles.

conclusionsTreatment with ridaforolimus combined with paclitaxel and carboplatin had no unanticipated toxicities and showed antineoplastic activity. The recommended phase II dose and schedule is ridaforolimus 30 mg (days 1-5 and 8-12) plus day 1 paclitaxel (175 mg/m

trial registrationClinicalTrials.gov Identifier: NCT01256268 (trial registration date: December 1, 2010).

Indexed as

Maximum Tolerated DoseResearch DesignAdministration, OralAdultAgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHumansMaleMiddle AgedNeoplasmsCarboplatinPaclitaxelridaforolimusSirolimusOral ridaforolimusPaclitaxel and carboplatin combinationPhase 1 trialSolid tumors

Identifiers

PMID28595616
PMCPMC5465458
OpenAlexW2623478857

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.