Trial Outcomes & Findings for Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer (NCT NCT00640978)
NCT ID: NCT00640978
Last Updated: 2025-05-01
Results Overview
Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-01
Participant Flow
Recruitment Period: March 2008 through January 20, 2009. All recruitment done at UT MD Anderson Cancer Center.
Of the sixteen registered, one (1) participant was enrolled but did not receive the planned treatment.
Participant milestones
| Measure |
Erlotinib + RAD001
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib + RAD001
n=15 Participants
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOverall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
Outcome measures
| Measure |
Erlotinib + RAD001
n=15 Participants
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
|
|---|---|
|
Number of Participants Surviving at 6 Months
|
15 Participants
Interval 34.0 to 75.0
|
Adverse Events
Erlotinib + RAD001
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erlotinib + RAD001
n=16 participants at risk
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
|
|---|---|
|
Metabolism and nutrition disorders
Hypoatremia
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Infections and infestations
Infection with normal neutrophils
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Blood and lymphatic system disorders
Leukocytes
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
31.2%
5/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Mood Alteration (Anxiety)
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Mucositis (oral)
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
18.8%
3/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain(joint)
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash (hand and foot eeaction)
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Rigor/chills
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Serum glutamic oxaloacetic transaminase (AST, SGOT)
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Serum glutamic pyruvic transaminase (ALT)
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Taste Alteration
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Vascular disorders
Thrombosis
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Investigations
Weight Loss
|
31.2%
5/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Xerostoma
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Reproductive system and breast disorders
Yeast infection
|
12.5%
2/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
31.2%
5/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
43.8%
7/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
31.2%
5/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Anorexia
|
37.5%
6/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Bilirubin
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Cholesterol (serum high)
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Confusion
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Dehydration
|
18.8%
3/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Dehyration
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
56.2%
9/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Distention/bloating
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Dizziness
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
18.8%
3/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Eye disorders
Dry eyes
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
General disorders
Fever without neutropenia
|
25.0%
4/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
3/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
4/16 • Adverse events data were collected from March 07, 2008 to August 12, 2008 or a total of 6 months.
|
Additional Information
Milind Javle, MD/Associate Professor
UT MD Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place