Trial Outcomes & Findings for Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma (NCT NCT00466687)
NCT ID: NCT00466687
Last Updated: 2013-07-22
Results Overview
Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
At 6 months
Results posted on
2013-07-22
Participant Flow
This study remained open from 09/15/2004 to 1/27/2006.
36 patients consented to be in the study, two were determined not eligible.
Participant milestones
| Measure |
Therapeutic Intervention
Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Therapeutic Intervention
Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Other complicating illness
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Disease progression
|
29
|
Baseline Characteristics
Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Therapeutic Intervention
n=34 Participants
Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Patients for whom a response could be determined. Three patients were not available for measurement of response: no data (2) and toxicity (1).
Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Tarceva/Avastin
n=31 Participants
Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
|
|---|---|
|
Number of Patients With Response
Complete Response
|
0 participants
|
|
Number of Patients With Response
Partial Response
|
2 participants
|
|
Number of Patients With Response
Stable Disease
|
14 participants
|
|
Number of Patients With Response
Progressive Disease
|
15 participants
|
SECONDARY outcome
Timeframe: up to one year after off-study datePopulation: Patients with disease progression. Six patients were not available for determination to progression: no data (5) and toxicity (1).
Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.
Outcome measures
| Measure |
Tarceva/Avastin
n=28 Participants
Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
|
|---|---|
|
Time to Disease Progression.
|
3 Months
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Those patients who were progression-free at 6 months from study entry. No date of progression was available for 7 patients
Patients with Progression-free survival at 6 months
Outcome measures
| Measure |
Tarceva/Avastin
n=27 Participants
Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
|
|---|---|
|
Progression-free Survival at 6 Months
|
7 participants
Interval 1.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 of each 28-day cycle for 6 cycles (168 days)Population: Patients who received the study drug and who experienced a toxicity. Eleven patients did not experience any toxicity and are therefore not included in the analyzed population for this outcome measure.
Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.
Outcome measures
| Measure |
Tarceva/Avastin
n=23 Participants
Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
|
|---|---|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 1
|
3 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 2
|
12 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 3
|
7 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 4
|
1 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 5
|
0 participants
|
Adverse Events
Therapeutic Intervention
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Therapeutic Intervention
n=34 participants at risk
Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
|
|---|---|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.9%
1/34 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - tumor
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
Edema limb-right leg
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
anorexia
|
5.9%
2/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
apnea
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
cardiac ischemia/infarction
|
2.9%
1/34 • Number of events 1
|
|
Renal and urinary disorders
confusion
|
2.9%
1/34 • Number of events 1
|
|
General disorders
death not associated with CTCAE term-disease progression NOS
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
5.9%
2/34 • Number of events 3
|
|
General disorders
fatigue
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
hypertension
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
hypotension
|
2.9%
1/34 • Number of events 1
|
|
Eye disorders
muscle weakness (not due to neuropathy) extra-occular
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness (not due to neuropathy) unable to walk
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness (not due to neuropathy) whole body
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
11.8%
4/34 • Number of events 5
|
|
Gastrointestinal disorders
pain abdomen
|
5.9%
2/34 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
pain back
|
2.9%
1/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pain buttock, pelvis
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain extremity, limb
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain neck
|
2.9%
1/34 • Number of events 2
|
|
Gastrointestinal disorders
colon perforation
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
pericardial effusion (non-malignant)
|
2.9%
1/34 • Number of events 1
|
|
Blood and lymphatic system disorders
platelets
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis/pulmonary infiltrates
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
somnolence
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
sweating
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
8.8%
3/34 • Number of events 4
|
Other adverse events
| Measure |
Therapeutic Intervention
n=34 participants at risk
Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
|
|---|---|
|
Investigations
alkaline phosphatase
|
14.7%
5/34 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
5.9%
2/34 • Number of events 20
|
|
Investigations
ALT, SGPT
|
8.8%
3/34 • Number of events 5
|
|
Metabolism and nutrition disorders
anorexia
|
38.2%
13/34 • Number of events 51
|
|
Investigations
AST, SGOT
|
11.8%
4/34 • Number of events 10
|
|
Hepatobiliary disorders
bilirubinemia-imcreased
|
5.9%
2/34 • Number of events 2
|
|
Cardiac disorders
Cardiac general-other
|
8.8%
3/34 • Number of events 9
|
|
Investigations
cholesterol, serum-high
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
14.7%
5/34 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.8%
3/34 • Number of events 32
|
|
Gastrointestinal disorders
diarrhea
|
29.4%
10/34 • Number of events 64
|
|
General disorders
fatigue
|
52.9%
18/34 • Number of events 104
|
|
General disorders
Fever (in the absence of neutropenia, with neutropenia defined as ANC < 1.0 x 10e9/L
|
5.9%
2/34 • Number of events 8
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
11.8%
4/34 • Number of events 22
|
|
Metabolism and nutrition disorders
glucose, serum-high
|
26.5%
9/34 • Number of events 24
|
|
Gastrointestinal disorders
heartburn, dyspepsia
|
11.8%
4/34 • Number of events 19
|
|
Investigations
hemoglobin
|
17.6%
6/34 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage, pulmonary/upper respiratory-lung
|
5.9%
2/34 • Number of events 8
|
|
Vascular disorders
hypertension
|
17.6%
6/34 • Number of events 41
|
|
Infections and infestations
infection with unknown-bladder (urinary)
|
5.9%
2/34 • Number of events 21
|
|
Psychiatric disorders
insomnia
|
8.8%
3/34 • Number of events 19
|
|
Metabolism and nutrition disorders
magnesium, serum low (hypomagnesemia)
|
11.8%
4/34 • Number of events 11
|
|
Psychiatric disorders
mood alteration-anxiety
|
5.9%
2/34 • Number of events 4
|
|
Psychiatric disorders
mood alteration-depression
|
11.8%
4/34 • Number of events 20
|
|
Infections and infestations
mucositis/stomatitis-oral cavity
|
5.9%
2/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal/soft tissue-other
|
5.9%
2/34 • Number of events 9
|
|
Gastrointestinal disorders
nausea
|
23.5%
8/34 • Number of events 55
|
|
Gastrointestinal disorders
pain-abdomen NOS
|
8.8%
3/34 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
pain-back
|
5.9%
2/34 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
pain-extremity. limb
|
8.8%
3/34 • Number of events 6
|
|
Nervous system disorders
pain-head/headache
|
11.8%
4/34 • Number of events 14
|
|
General disorders
pain-other
|
8.8%
3/34 • Number of events 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pain-tumor
|
8.8%
3/34 • Number of events 6
|
|
Metabolism and nutrition disorders
potassium, serum-low (hypokalemia)
|
11.8%
4/34 • Number of events 6
|
|
Renal and urinary disorders
proteinuria
|
8.8%
3/34 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
pruritis
|
14.7%
5/34 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
14.7%
5/34 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
rash acne/acneiform
|
35.3%
12/34 • Number of events 91
|
|
Renal and urinary disorders
renal/genitourinary-other
|
5.9%
2/34 • Number of events 12
|
|
Metabolism and nutrition disorders
sodium, serum-low (hyponatremia)
|
11.8%
4/34 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
sweating/diphoresis
|
5.9%
2/34 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
voice changes/dysarthria
|
8.8%
3/34 • Number of events 21
|
|
Gastrointestinal disorders
vomiting
|
11.8%
4/34 • Number of events 12
|
|
Metabolism and nutrition disorders
weight loss
|
8.8%
3/34 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place