Trial Outcomes & Findings for Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye (NCT NCT00329641)

Last Updated: 2014-07-31

Results Overview

Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression

Results posted on

2014-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib, Carboplatin, Paclitaxel Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
Overall Study STARTED	25
Overall Study Eligible	25
Overall Study Eligible and Received Treatment	24
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib, Carboplatin, Paclitaxel Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
Overall Study Did not start treatment	1
Overall Study Not eligible	1
Overall Study Adverse Event	3
Overall Study Other reason, not protocol specified	1

Baseline Characteristics

Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib, Carboplatin, Paclitaxel n=24 Participants
Age, Continuous	61 Years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	24 participants n=99 Participants

PRIMARY outcome

Timeframe: Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression

Population: Eligible patients who received some treatment

Outcome measures

Outcome measures
Measure	Sorafenib, Carboplatin, Paclitaxel n=24 Participants
Response Rate (Complete and Partial Response)	0 participants

SECONDARY outcome

Timeframe: Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death

Population: Eligible patients who received some treatment

Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact

Outcome measures

Outcome measures
Measure	Sorafenib, Carboplatin, Paclitaxel n=24 Participants
One-year Overall Survival	42 Percentage of population Interval 22.0 to 60.0

SECONDARY outcome

Timeframe: Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death

Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact

Outcome measures

Outcome measures
Measure	Sorafenib, Carboplatin, Paclitaxel n=24 Participants
6-month Progression-free Survival	29 Percent of population Interval 13.0 to 48.0

SECONDARY outcome

Timeframe: Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)

Population: Eligible patients who started therapy

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Outcome measures

Outcome measures
Measure	Sorafenib, Carboplatin, Paclitaxel n=24 Participants
Toxicity Cataract	1 Participants with a given type of AE
Toxicity Calcium, serum-low (hypocalcemia)	1 Participants with a given type of AE
Toxicity Diarrhea	2 Participants with a given type of AE
Toxicity Fatigue (asthenia, lethargy, malaise)	1 Participants with a given type of AE
Toxicity Febrile neutropenia	1 Participants with a given type of AE
Toxicity Hemoglobin	2 Participants with a given type of AE
Toxicity Infec w/ Gr 3/4 neut-Urinary tract	1 Participants with a given type of AE
Toxicity Leukocytes (total WBC)	4 Participants with a given type of AE
Toxicity Lymphopenia	2 Participants with a given type of AE
Toxicity Mucositis/stomatitis (func/symp) - Pharynx	1 Participants with a given type of AE
Toxicity Neuropathy: sensory	2 Participants with a given type of AE
Toxicity Neutrophils/granulocytes (ANC/AGC)	10 Participants with a given type of AE
Toxicity Platelets	4 Participants with a given type of AE
Toxicity Pruritus/itching	1 Participants with a given type of AE
Toxicity Rash/desquamation	5 Participants with a given type of AE
Toxicity Vision-blurred vision	1 Participants with a given type of AE

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=24 participants at risk Sorafenib, Carboplatin, Paclitaxel
Investigations Neutrophils/granulocytes (ANC/AGC)	4.2% 1/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Rash/desquamation	4.2% 1/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment

Other adverse events

Other adverse events
Measure	Intervention n=24 participants at risk Sorafenib, Carboplatin, Paclitaxel
Blood and lymphatic system disorders Hemoglobin	20.8% 5/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Eye disorders Vision-blurred vision	12.5% 3/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Constipation	12.5% 3/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Diarrhea	45.8% 11/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Gastrointestinal-Other (Specify)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Nausea	16.7% 4/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Pain - Abdomen NOS	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Gastrointestinal disorders Vomiting	29.2% 7/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
General disorders Edema: limb	12.5% 3/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
General disorders Fatigue (asthenia, lethargy, malaise)	66.7% 16/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Leukocytes (total WBC)	29.2% 7/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Lymphopenia	16.7% 4/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Metabolic/Laboratory-Other (Specify)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Neutrophils/granulocytes (ANC/AGC)	41.7% 10/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Platelets	29.2% 7/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Investigations Weight loss	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Metabolism and nutrition disorders Anorexia	29.2% 7/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	12.5% 3/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Joint	16.7% 4/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Musculoskeletal and connective tissue disorders Pain - Muscle	25.0% 6/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Nervous system disorders Neuropathy: motor	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Nervous system disorders Neuropathy: sensory	79.2% 19/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Nervous system disorders Taste alteration (dysgeusia)	16.7% 4/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Psychiatric disorders Insomnia	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	8.3% 2/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	12.5% 3/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	41.7% 10/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Pruritus/itching	25.0% 6/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Rash/desquamation	50.0% 12/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Rash: acne/acneiform	16.7% 4/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	25.0% 6/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment
Vascular disorders Hypertension	25.0% 6/24 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported Regular investigator assessments are reported after each cycle of protocol treatment

Additional Information

SWOG Melanoma Statistician

SWOG Statistical Office

Phone: 206-667-4408

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60