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Alkylating agents

Gemcitabine/Carboplatin for Genital Warts

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
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 stopping treatment up to 82 months
Awards & highlights

Summary

This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

Eligible Conditions
  • Genital Warts
  • Pelvic Tumors
  • Fallopian Tube Cancer
  • Ovarian Tumors
  • Peritoneal Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to stopping treatment up to 82 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to stopping treatment up to 82 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Overall Survival
Proportion of Participants With Response (Response Rate)
Time to Treatment Failure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gemcitabine/CarboplatinExperimental Treatment2 Interventions
Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles
Group II: Paclitaxel/CarboplatinActive Control2 Interventions
Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Carboplatin
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,652 Previous Clinical Trials
3,223,567 Total Patients Enrolled
Study DirectorEli Lilly and Company
~40 spots leftby Oct 2025
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