Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer

NCT00640978 | Terminated Phase 2 Results

• 1 other identifier: 2007-0666
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied. Primary Objectives:

• Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer. Secondary Objectives:
• Determine the progression-free survival (PFS).
• Determine the response rate (RR).

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Advanced Pancreatic Cancer; Unresectable; Metastatic; RAD001; Everolimus; Erlotinib; OSI-774; Erlotinib Hydrochloride; Tarceva

Outcome Measures

Primary Outcomes (1)

• Number of Participants Surviving at 6 Months

  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.

  6 months

Study Arms (1)

Erlotinib + RAD001

EXPERIMENTAL

Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks

Drug: RAD001; Drug: Erlotinib

Interventions

RAD001 DRUG

30 mg orally weekly for 4 weeks

Also known as: Everolimus

Erlotinib + RAD001

Erlotinib DRUG

150 mg by mouth daily for 28 Days

Also known as: Erlotinib Hydrochloride, OSI-774, Tarceva

Erlotinib + RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
• Patients must have received at least one prior chemotherapy regimen for unresectable/ metastatic disease. There is no limit to number of prior regimens. Prior erlotinib therapy is allowed.
• Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Patients must have recovered from the acute toxicities of any prior therapy to NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 \</= Grade 1.
• Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of erlotinib administered in combination with RAD001 in patients \< 18 years of age, children are excluded from this study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients must have at least one measurable site of disease according to Response Evaluation Criteria In Solid Tumors (RECIST). This site must be outside a radiation field.
• Adequate hematologic, hepatic and renal parameters: leukocytes =/\>3,000/ul, absolute neutrophil count =/\>1,500/ul, platelets =/\>100,000/ul, hemoglobin =/\>9g/dL, total bilirubin \</= 1.5 mg/dl, aspartate aminotransferase (AST) \</=230 and alanine aminotransferase (ALT) \</=280 IU/L for subjects with documented liver metastases; AST \</=115 and ALT \</=140 IU/L for subjects without evidence of liver metastases, creatinine \</=1.5 mg/dl in males, \</= 1.2 mg/dl in females.
• Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry for the duration of study treatment and 30 days after the end of treatment. WOCBP is defined as a woman who has not been naturally postmenopausal for at least 12 consecutive months or no previous surgical sterilization. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and are therefore not considered effective for this study. WOCBP must provide a negative pregnancy test (serum or urine) within 7 days prior to treatment.
• (Continuation of # 8) Acceptable contraception includes double-barrier methods (any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap, IUD).
• Signed written informed consent document. Written informed consent must be obtained prior to any evaluations being performed solely for the purposes of screening for eligibility for this study.

You may not qualify if:

• Prior treatment with any investigational drug within the preceding 2 weeks
• Chronic treatment with systemic steroids or another immunosuppressive agent. Patients can not receive immunization with attenuated live vaccines within one week of study entry or during study period
• Limits for fasting lipids must be: cholesterol \</= 300mg/dL and triglyceride \</= 2.5 times upper limits of normal (ULN). Patients may be allowed to enroll on the trial after initiation of lipid lowering agents
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms)
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \</= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function (oxygen dependent, Common Terminology Criteria (CTC) Grade 3 or 4 dyspnea); uncontrolled diabetes as defined by fasting serum glucose \>1.5 times ULN; any active (acute or chronic) or uncontrolled infection / disorders
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy ; liver disease such as cirrhosis, known chronic active hepatitis or chronic persistent hepatitis; A known history of HIV seropositivity
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 and/or erlotinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients with an active, bleeding diathesis (if coumarin is used, weekly monitoring is recommended)
• Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Acceptable contraception includes double-barrier methods (any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap, intrauterine device \[IUD\]).
• Patients who have received prior treatment with an mTor inhibitor
• Patients with a known hypersensitivity to erlotinib, RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer. 2010 Jul 14;10:368. doi: 10.1186/1471-2407-10-368.

  PMID: 20630061 RESULT

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Everolimus; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Milind Javle, MD/Associate Professor
• Organization: UT MD Anderson Cancer Center

mjlim@mdanderson.org

713-792-2828

Study Officials

• Milind Javle, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 1, 2025
• Results First Posted: September 27, 2011

Record last verified: 2025-04

Locations

US (1)