Carboplatin for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial Cancer+2 MoreCarboplatin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is studying how well different treatment regimens work in treating patients with serous or p53 abnormal endometrial cancer.

Eligible Conditions
  • Endometrial Cancer
  • TP53 Mutation
  • Serous Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 5 years

3 years
Disease Free Survival Rate
5 years
Number Adverse Events Experienced
Overall Survival Rate

Trial Safety

Safety Progress

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

Side Effects for

10 MG/KG Ipilimumab + Paclitaxel/ Carbop
38%Alopecia
36%Anaemia
32%Nausea
31%Decreased appetite
31%Diarrhoea
30%Fatigue
25%Constipation
23%Neutropenia
20%Dyspnoea
19%Pyrexia
19%Vomiting
18%Rash
17%Cough
17%Asthenia
16%Arthralgia
16%Pruritus
16%Thrombocytopenia
15%Peripheral sensory neuropathy
14%Myalgia
13%Neuropathy peripheral
13%Insomnia
11%Hypokalaemia
10%Platelet count decreased
9%Pain in extremity
9%Leukopenia
9%Weight decreased
8%Hyponatraemia
8%Pneumonia
8%Alanine aminotransferase increased
8%Haemoglobin decreased
7%Back pain
7%Malignant neoplasm progression
7%Neutrophil count decreased
7%Aspartate aminotransferase increased
7%Dizziness
7%Bone pain
7%Haemoptysis
6%Hypomagnesaemia
6%Stomatitis
6%Headache
5%Abdominal pain
5%Oedema peripheral
5%Chest pain
5%Abdominal pain upper
5%White blood cell count decreased
5%Dehydration
4%Musculoskeletal pain
4%Febrile neutropenia
4%Paraesthesia
3%Colitis
2%Lung infection
2%Pulmonary embolism
2%Death
2%Mucosal inflammation
1%Cardio-respiratory arrest
1%Pulmonary haemorrhage
1%Interstitial lung disease
1%Urinary tract infection
1%Chronic obstructive pulmonary disease
1%Pneumothorax
1%Confusional state
1%Drug hypersensitivity
1%Cerebrovascular accident
1%Lung abscess
1%Multi-organ failure
1%Blood creatinine increased
1%Metastases to central nervous system
1%Atrial fibrillation
1%Disease progression
1%Renal failure
1%Liver function test abnormal
1%Lower respiratory tract infection
1%Lung neoplasm malignant
1%Pain
1%Acute kidney injury
1%Hypersensitivity
1%General physical health deterioration
1%Intestinal perforation
1%Infection
1%Pneumonitis
1%Respiratory failure
1%Syncope
1%Hyperglycaemia
1%Sudden death
1%Sepsis
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01285609) in the 10 MG/KG Ipilimumab + Paclitaxel/ Carbop ARM group. Side effects include: Alopecia with 38%, Anaemia with 36%, Nausea with 32%, Decreased appetite with 31%, Diarrhoea with 31%.

Trial Design

5 Treatment Groups

Exploratory Cohort
1 of 5
Early Stage Cohort - Arm A
1 of 5
Advanced Stage Cohort Arm C
1 of 5
Early Stage Cohort - Arm B1
1 of 5
Advanced Stage Cohort Arm D1
1 of 5

Active Control

Experimental Treatment

120 Total Participants · 5 Treatment Groups

Primary Treatment: Carboplatin · No Placebo Group · Phase 2 & 3

Early Stage Cohort - Arm AExperimental Group · 2 Interventions: Paclitaxel, Carboplatin · Intervention Types: Drug, Drug
Advanced Stage Cohort Arm CExperimental Group · 2 Interventions: Paclitaxel, Carboplatin · Intervention Types: Drug, Drug
Early Stage Cohort - Arm B1Experimental Group · 4 Interventions: Paclitaxel, Cisplatin, External Beam Radiation, Carboplatin · Intervention Types: Drug, Drug, Radiation, Drug
Advanced Stage Cohort Arm D1Experimental Group · 3 Interventions: Paclitaxel, Niraparib, Carboplatin · Intervention Types: Drug, Drug, Drug
Exploratory CohortNoIntervention Group · 1 Intervention: Exploratory Cohort · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Cisplatin
FDA approved
Niraparib
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,382 Previous Clinical Trials
473,355 Total Patients Enrolled
5 Trials studying Endometrial Cancer
879 Patients Enrolled for Endometrial Cancer
Amit Oza, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
4 Previous Clinical Trials
619 Total Patients Enrolled
1 Trials studying Endometrial Cancer
44 Patients Enrolled for Endometrial Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The Eastern Cooperative Group (ECOG) has a performance status of ≤ 2 (Karnofsky ≥ 60%).
The subject is able to understand the information presented in the written informed consent document and is willing to sign it.
Women who could possibly become pregnant must use effective birth control methods before, during, and for a month after taking the study drug.
If a patient does not have any archival tissue available, a tumor biopsy will be mandatory in order to obtain the necessary tissue for diagnosis.
The proposed treatment must be started within 8 days for patients to have normal organ and marrow function.
Patients with stage I or II tumors will be enrolled in the early stage cohort.
Some patients are suitable for the best surgery possible.
Patients with pure serous endometrial carcinoma, or with endometrioid or clear cell carcinoma and abnormal/mutant-type p53, will be included.
The Central office must have access to local TP53 results.
The patient is expected to live for more than three months.