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Alkylating agents

Paclitaxel for Ovarian Granulosa Cell Tumor

Phase 2
Waitlist Available
Led By Jubilee Brown
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 2 years
Awards & highlights

Study Summary

This trial is comparing 3 different chemotherapy drugs to treat patients with sex cord-ovarian stromal tumors.

Eligible Conditions
  • Ovarian Granulosa Cell Tumor
  • Gynandroblastoma
  • Sertoli-Leydig Cell Tumor
  • Ovarian Sex Cord Tumor
  • Ovarian Tumors
  • Ovarian Sex Cord-Stromal Tumor
  • Ovarian Steroid Cell Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Tumor Response Rate
Other outcome measures
Change in Inhibin A and Inhibin B Levels

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)Experimental Treatment4 Interventions
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (paclitaxel, carboplatin)Experimental Treatment3 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bleomycin Sulfate
2010
Completed Phase 3
~1960
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Etoposide Phosphate
2011
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,842 Total Patients Enrolled
1 Trials studying Ovarian Granulosa Cell Tumor
36 Patients Enrolled for Ovarian Granulosa Cell Tumor
GOG FoundationLead Sponsor
42 Previous Clinical Trials
16,678 Total Patients Enrolled
Jubilee BrownPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Ovarian Granulosa Cell Tumor
36 Patients Enrolled for Ovarian Granulosa Cell Tumor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
2010. "Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01042522.
All > Acl
~4 spots leftby Apr 2025
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