Trial Outcomes & Findings for Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma (NCT NCT01093222)
NCT ID: NCT01093222
Last Updated: 2015-06-30
Results Overview
From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-06-30
Participant Flow
Participant milestones
| Measure |
Sorafenib and Erlotinib
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
Eligible and Began Protocol Therapy
|
34
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Sorafenib and Erlotinib
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Ineligible
|
6
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Progression/relapse
|
24
|
|
Overall Study
Death
|
2
|
|
Overall Study
Not protocol specified
|
1
|
Baseline Characteristics
Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Sorafenib and Erlotinib
n=34 Participants
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Zubrod Performance Status
0
|
19 participants
n=5 Participants
|
|
Zubrod Performance Status
1
|
15 participants
n=5 Participants
|
|
Chemotherapy, multiple agents
Yes
|
1 participants
n=5 Participants
|
|
Chemotherapy, multiple agents
No
|
33 participants
n=5 Participants
|
|
Prior Surgery
Yes
|
14 participants
n=5 Participants
|
|
Prior Surgery
No
|
20 participants
n=5 Participants
|
|
Current Status of Disease
Distant Metastatic
|
28 participants
n=5 Participants
|
|
Current Status of Disease
Locally Advanced
|
6 participants
n=5 Participants
|
|
Primary Cancer
Cholangiocarcinoma
|
20 participants
n=5 Participants
|
|
Primary Cancer
Gallbladder
|
14 participants
n=5 Participants
|
|
Prior Radiation Therapy
Yes
|
0 participants
n=5 Participants
|
|
Prior Radiation Therapy
No
|
34 participants
n=5 Participants
|
|
Setting of Prior Chemotherapy
Adjuvant
|
1 participants
n=5 Participants
|
|
Setting of Prior Chemotherapy
Neoadjuvant
|
0 participants
n=5 Participants
|
|
Setting of Prior Chemotherapy
None
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who began protocol therapy
From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Outcome measures
| Measure |
Sorafenib and Erlotinib
n=34 Participants
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
2 months
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who began protocol therapy
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Sorafenib and Erlotinib
n=34 Participants
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
6 months
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who began protocol therapy
Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Outcome measures
| Measure |
Sorafenib and Erlotinib
n=34 Participants
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response
|
6 percentage of participants
Interval 1.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Sorafenib and Erlotinib
n=34 Participants
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Abdominal pain
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Alanine aminotransferase increased
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Alkaline phosphatase increased
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Allergic reaction
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Aspartate aminotransferase increased
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Blood bilirubin increased
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Death NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Erythema multiforme
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Gastric perforation
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hepatic failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hepatic infection
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hepatic necrosis
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypertension
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypoalbuminemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypokalemia
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypophosphatemia
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphocyte count decreased
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis oral
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Palmar-plantar erythrodysesthesia syndrome
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelet count decreased
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash acneiform
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash maculo-papular
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thromboembolic event
|
1 Participants
|
Adverse Events
Sorafenib and Erlotinib
Serious events: 17 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib and Erlotinib
n=34 participants at risk
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
4/34 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Gastric perforation
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/34 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Up to 3 years
|
|
General disorders
Death NOS
|
17.6%
6/34 • Up to 3 years
|
|
General disorders
Multi-organ failure
|
2.9%
1/34 • Up to 3 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.9%
1/34 • Up to 3 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.9%
1/34 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatic necrosis
|
2.9%
1/34 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.9%
1/34 • Up to 3 years
|
|
Immune system disorders
Allergic reaction
|
2.9%
1/34 • Up to 3 years
|
|
Infections and infestations
Device related infection
|
2.9%
1/34 • Up to 3 years
|
|
Infections and infestations
Hepatic infection
|
2.9%
1/34 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
2.9%
1/34 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
8.8%
3/34 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
2/34 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
11.8%
4/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
2/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/34 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
2.9%
1/34 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Up to 3 years
|
|
Nervous system disorders
Lethargy
|
2.9%
1/34 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/34 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Up to 3 years
|
Other adverse events
| Measure |
Sorafenib and Erlotinib
n=34 participants at risk
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
INR increased
|
5.9%
2/34 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
17.6%
6/34 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
29.4%
10/34 • Up to 3 years
|
|
Investigations
Weight loss
|
26.5%
9/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
29.4%
10/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.3%
12/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.4%
10/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.6%
6/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
2/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.3%
12/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
2/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.5%
9/34 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.5%
8/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
6/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.5%
9/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.8%
3/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
3/34 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.6%
7/34 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Up to 3 years
|
|
Nervous system disorders
Dysarthria
|
5.9%
2/34 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
8.8%
3/34 • Up to 3 years
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
2/34 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • Up to 3 years
|
|
Renal and urinary disorders
Urine discoloration
|
5.9%
2/34 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
2/34 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.8%
3/34 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.9%
2/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
6/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.7%
5/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
2/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
29.4%
10/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
3/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
17/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.4%
11/34 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
2/34 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
35.3%
12/34 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
5.9%
2/34 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
32.4%
11/34 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
2/34 • Up to 3 years
|
|
Eye disorders
Conjunctivitis
|
5.9%
2/34 • Up to 3 years
|
|
Eye disorders
Dry eye
|
5.9%
2/34 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
8.8%
3/34 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
38.2%
13/34 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
44.1%
15/34 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
20/34 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
4/34 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
6/34 • Up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
8.8%
3/34 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
29.4%
10/34 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
17/34 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
8.8%
3/34 • Up to 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.8%
3/34 • Up to 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
5.9%
2/34 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
6/34 • Up to 3 years
|
|
General disorders
Chills
|
5.9%
2/34 • Up to 3 years
|
|
General disorders
Edema limbs
|
17.6%
6/34 • Up to 3 years
|
|
General disorders
Fatigue
|
50.0%
17/34 • Up to 3 years
|
|
General disorders
Fever
|
5.9%
2/34 • Up to 3 years
|
|
General disorders
Flu like symptoms
|
5.9%
2/34 • Up to 3 years
|
|
General disorders
Pain
|
17.6%
6/34 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
8.8%
3/34 • Up to 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.9%
2/34 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
52.9%
18/34 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
17/34 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
64.7%
22/34 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
35.3%
12/34 • Up to 3 years
|
|
Investigations
Creatinine increased
|
5.9%
2/34 • Up to 3 years
|
Additional Information
Study Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60