Paclitaxel for Fallopian Tube Carcinoma

Ohio State University Comprehensive Cancer Center, Columbus, OH
Fallopian Tube Carcinoma+6 More ConditionsPaclitaxel - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trialwill study a 3-drug combo for recurrent endometrial & ovarian cancer to see if it's safe & effective w/ manageable side effects.

Eligible Conditions
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Recurrent Ovarian Cancer
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Endometrial Cancer
  • Platinum-resistant Ovarian Cancer
  • Recurrent Fallopian Tube Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
Objective tumor response
Progression free survival
Safety and Toxicity

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
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%Alanine aminotransferase increased
13%Neurotoxicity
13%Cough
13%Vomting
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1 Treatment Group

Treatment (paclitaxel, lenvatinib, pembrolizumab)
1 of 1

Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Paclitaxel · No Placebo Group · Phase 2

Treatment (paclitaxel, lenvatinib, pembrolizumab)Experimental Group · 3 Interventions: Lenvatinib, Paclitaxel, Pembrolizumab · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Paclitaxel
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Floor BackesLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinoma
26 Patients Enrolled for Fallopian Tube Carcinoma
Floor Backes, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
5 Previous Clinical Trials
302 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinoma
26 Patients Enrolled for Fallopian Tube Carcinoma

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are allowed to have had treatment with PD-1/PD-L1 inhibitors or weekly paclitaxel, as long as you did not recently stop the treatment because of side effects or toxicity.