Evidence map›Paper›PMID 19264351›Full record

Trial reportGynecologic oncology2009

A phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer.

Kathleen M Schmeler, Saroj Vadhan-Raj, Pedro T Ramirez, Sachin M Apte, Lorenzo Cohen, Roland L Bassett, Revathy B Iyer, Judith K Wolf, Charles L Levenback, David M Gershenson and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00501644 (A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00501644 phase2completednot on this map

A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2003 to 2009Enrolled59ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal CancerArmsCarboplatin, GM-CSF (Sargramostim), Interferon Gamma
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. MHC-I-Driven Antitumor Immunity Counterbalances Low Absorbed Doses of Radiopharmaceutical Therapy.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Article
  3. Article
  4. Review
  5. Review
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  7. Article
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  9. Review
  10. Sex Differences in the Inflammatory Consequences of Stress: Implications for Pharmacotherapy.The Journal of pharmacology and experimental therapeutics · 2020
    Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Particle platforms for cancer immunotherapy.International journal of nanomedicine · 2013
    Review
  18. Immunotherapy in ovarian cancer.Human vaccines & immunotherapeutics · 2012
    Review
  19. Article
  20. 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

11 authors.

Kathleen M SchmelerDepartment of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77230-1439, USA. kschmele@mdanderson.org
Saroj Vadhan-Raj
Pedro T Ramirez
Sachin M Apte
Lorenzo Cohen
Roland L Bassett
Revathy B Iyer
Judith K Wolf
Charles L Levenback
David M Gershenson
Ralph S Freedman

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Kathrin Milbury · 1985 to 2026
$290.8M
Training of Academic Gynecologic OncologistsT32CA101642 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI ANIL K SOOD, Kathleen Schmeler · 2005 to 2026
$9.2M
NCI NIH HHS P30 CA016672NCI NIH HHS T32 CA101642
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and toxicity of carboplatin, granulocyte-macrophage colony-stimulating factor (GM-CSF) and recombinant interferon gamma 1b (rIFN-gamma1b) in women with recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer.

methodsIn this phase II study, patients with recurrent, platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer were treated with subcutaneous GM-CSF and rIFN-gamma1b before and after intravenous carboplatin until disease progression or unacceptable toxicity. All patients had measurable disease and a chemotherapy-free interval >6 months. Response was determined using RECIST criteria and CA 125 levels.

resultsBetween 2003 and 2007, 59 patients received a median of 6 cycles of therapy (range, 1 to 13 cycles). Median age at enrollment was 61 years (range, 35 to 79 years). Median time to progression prior to enrollment was 11 months (range, 6 to 58 months). Of 54 patients evaluable for response, 9 (17%) had a complete response, 21 (39%) had a partial response, and 24 (44%) had progressive disease. The overall response rate was 56% (95% CI: 41% to 69%). With a median follow-up of 6.4 months, median time to progression was 6 months. Myeloid derived cells and platelets increased on day 9 of each chemotherapy cycle. The most common adverse effects were bone marrow suppression, carboplatin hypersensitivity, and fatigue. Responders reported improved quality of life.

conclusionThis pre and post-carboplatin cytokine regimen resulted in a reasonable response and a hematologic profile that could invite further evaluation of its components in the treatment of patients with ovarian cancer.

Indexed as

AdultAgedAntibody-Dependent Cell CytotoxicityAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDisease-Free SurvivalFallopian Tube NeoplasmsFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansInterferon-gammaMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPeritoneal NeoplasmsQuality of LifeCarboplatinGranulocyte-Macrophage Colony-Stimulating FactorInterferon-gammaRecombinant Proteins

Identifiers

PMID19264351
PMCPMC4261621

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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.