Trial Outcomes & Findings for Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma (NCT NCT01014351)
NCT ID: NCT01014351
Last Updated: 2014-03-26
Results Overview
Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
18 months
Results posted on
2014-03-26
Participant Flow
Participant milestones
| Measure |
Paclitaxel/Carboplatin/Everolimus
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 Participants
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsProgression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 Participants
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
4.04 Months
Interval 2.76 to 4.99
|
SECONDARY outcome
Timeframe: 18 monthsOverall survival (OS) is defined as the time from randomization until death from any cause.
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 Participants
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Overall Survival (OS)
|
10.12 Months
Interval 7.29 to 10.87
|
SECONDARY outcome
Timeframe: 18 monthsObjective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 Participants
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Objective Response Rate (ORR)
|
17 percentage of patients
|
Adverse Events
Paclitaxel/Carboplatin/Everolimus
Serious events: 29 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 participants at risk
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
Vascular disorders
Acute angioedema
|
1.4%
1/70 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Fatigue
|
1.4%
1/70 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
3/70 • Number of events 4
|
|
General disorders
Fever
|
4.3%
3/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.4%
1/70 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.3%
3/70 • Number of events 3
|
|
Nervous system disorders
Hemorrhage, CNS
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
2.9%
2/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - nose
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Infection - bone (osteomyelitis)
|
1.4%
1/70 • Number of events 2
|
|
Infections and infestations
Infection - lung (pneumonia)
|
1.4%
1/70 • Number of events 1
|
|
Psychiatric disorders
Mental status
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - extremity-lower
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - generalized
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
14.3%
10/70 • Number of events 10
|
|
Blood and lymphatic system disorders
Platelets
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access)
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.6%
6/70 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70 • Number of events 1
|
Other adverse events
| Measure |
Paclitaxel/Carboplatin/Everolimus
n=70 participants at risk
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
|
|---|---|
|
General disorders
Fatigue
|
75.7%
53/70
|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.7%
46/70
|
|
Investigations
Platelets
|
55.7%
39/70
|
|
Gastrointestinal disorders
Nausea
|
54.3%
38/70
|
|
Investigations
Neutrophils/granulocytes
|
47.1%
33/70
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
45.7%
32/70
|
|
Nervous system disorders
Neuropathy: sensory
|
44.3%
31/70
|
|
Investigations
Leukocytes (total WBC)
|
42.9%
30/70
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
38.6%
27/70
|
|
Gastrointestinal disorders
Diarrhea
|
38.6%
27/70
|
|
Gastrointestinal disorders
Constipation
|
34.3%
24/70
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high
|
31.4%
22/70
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
21/70
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
30.0%
21/70
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
20/70
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
28.6%
20/70
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
27.1%
19/70
|
|
Investigations
Cholesterol, serum-high
|
24.3%
17/70
|
|
Musculoskeletal and connective tissue disorders
Pain - bone
|
22.9%
16/70
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
21.4%
15/70
|
|
General disorders
Edema
|
21.4%
15/70
|
|
Musculoskeletal and connective tissue disorders
Pain - muscle
|
20.0%
14/70
|
|
Investigations
Weight loss
|
18.6%
13/70
|
|
Nervous system disorders
Dizziness
|
18.6%
13/70
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
12/70
|
|
Metabolism and nutrition disorders
Creatinine
|
17.1%
12/70
|
|
General disorders
Fever
|
17.1%
12/70
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
15.7%
11/70
|
|
Psychiatric disorders
Insomnia
|
15.7%
11/70
|
|
General disorders
Pain
|
14.3%
10/70
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - nose
|
14.3%
10/70
|
|
Investigations
Alkaline phosphatase
|
14.3%
10/70
|
|
Metabolism and nutrition disorders
Calcium - serum-low
|
14.3%
10/70
|
|
Nervous system disorders
Paresthesia
|
12.9%
9/70
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.9%
9/70
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
12.9%
9/70
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
9/70
|
|
Metabolism and nutrition disorders
Sodium, serum-low
|
12.9%
9/70
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
11.4%
8/70
|
|
Gastrointestinal disorders
Pain - abdomen NOS
|
11.4%
8/70
|
|
General disorders
Rigors/chills
|
10.0%
7/70
|
|
Musculoskeletal and connective tissue disorders
Pain - extremity
|
10.0%
7/70
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - other
|
10.0%
7/70
|
|
Nervous system disorders
Pain - head
|
10.0%
7/70
|
|
Investigations
AST, SGOT
|
10.0%
7/70
|
|
Investigations
ALT, SGPT
|
8.6%
6/70
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
8.6%
6/70
|
|
Infections and infestations
Infection
|
8.6%
6/70
|
|
Psychiatric disorders
Mood alteration - depression
|
8.6%
6/70
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
7.1%
5/70
|
|
Psychiatric disorders
Mood alteration - anxiety
|
7.1%
5/70
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
7.1%
5/70
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
7.1%
5/70
|
|
Metabolism and nutrition disorders
Potassium, serum-high
|
7.1%
5/70
|
|
Respiratory, thoracic and mediastinal disorders
Pain - throat
|
5.7%
4/70
|
|
Eye disorders
Ocular/visual - other
|
5.7%
4/70
|
|
Metabolism and nutrition disorders
Albumin, serum-low
|
5.7%
4/70
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-high
|
5.7%
4/70
|
|
Metabolism and nutrition disorders
Magnesium, serum-low
|
5.7%
4/70
|
|
General disorders
Pain - chest
|
5.7%
4/70
|
|
General disorders
BUN levels decreased
|
5.7%
4/70
|
|
Vascular disorders
Flushing
|
5.7%
4/70
|
|
General disorders
BUN levels increased
|
5.7%
4/70
|
|
Investigations
Hypobilirubinemia
|
5.7%
4/70
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drainage
|
5.7%
4/70
|
|
General disorders
Extremity-lower (gait/walking)
|
5.7%
4/70
|
Additional Information
John D. Hainsworth, M.D.
SCRI Development Innovations LLC
Phone: 615-329-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER