Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033241
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )

Brief Summary:

RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed, gemcitabine-naive, locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the objective antitumor response rate and response duration in patients treated with this regimen.
  • Determine the time to disease progression and duration of overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of erlotinib.

Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated at the MTD as above.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advanced Pancreatic Carcinoma Or Other Potentially Responsive Malignancies
Actual Study Start Date : July 23, 2001
Actual Primary Completion Date : April 22, 2004
Actual Study Completion Date : April 22, 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed locally advanced or metastatic epithelial carcinoma of the pancreas or other malignancy considered to be potentially responsive to gemcitabine

    • Newly diagnosed or gemcitabine naive
  • Measurable or evaluable disease
  • Not amenable to surgical intervention due to medical contraindications or non-resectability of the tumor
  • No islet cell tumors or other non-epithelial cell carcinomas of the pancreas
  • No active CNS metastases or leptomeningeal disease

    • Treated or asymptomatic brain metastases are allowed if on a stable dose of corticosteroids and/or there is no change in brain disease status for at least 4 weeks after related therapy (e.g., whole-brain radiotherapy)



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL (except for documented Gilbert's syndrome)
  • AST or ALT less than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if hepatic obstruction or metastases present)
  • Albumin at least 2.5 g/dL


  • Creatinine less than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No significant cardiovascular disease
  • No history of congestive heart failure currently requiring therapy
  • No ventricular arrhythmia requiring anti-arrhythmic therapy
  • No severe conduction disturbances
  • No angina pectoris requiring therapy
  • No myocardial infarction within the past 6 months


  • No significant gastrointestinal abnormalities including:

    • Requirement for IV alimentation
    • Active peptic ulcer disease


  • No significant ophthalmologic abnormalities including:

    • Severe dry eye syndrome
    • Keratoconjunctivitis sicca
    • Sjogren's syndrome
    • Severe exposure keratopathy
    • Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
    • Abnormal Schirmer test (less than 2 mm) allowed provided there is no evidence of clinically significant corneal surface abnormalities


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known or suspected hypersensitivity to gemcitabine
  • No uncontrolled infection
  • HIV negative
  • No other malignancy within the past 5 years except treated non-melanoma skin cancer or carcinoma in situ of the breast or cervix
  • No other life-threatening illness
  • No psychiatric disorders or altered mental status the would preclude informed consent or study


Biologic therapy:

  • At least 28 days since prior immunotherapy or biological response modified therapy for the primary malignancy
  • No concurrent immunotherapy or biologic response modifier therapy for the primary malignancy


  • See Disease Characteristics
  • At least 28 days since prior chemotherapy for the primary malignancy
  • No prior mitomycin or nitrosoureas for the primary malignancy
  • No more than 6 prior courses of chemotherapy with an alkylating agent for the primary malignancy
  • No prior gemcitabine for the primary malignancy except as a low-dose (less than 500 mg/m^2) radiosensitizer administered concurrently with or within 2 weeks after radiotherapy at least 3 months ago
  • No other concurrent chemotherapy for the primary malignancy

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior systemic hormonal therapy (except LH-RH agonists) for the primary malignancy
  • No concurrent systemic hormonal therapy (except LH-RH agonists) for the primary malignancy
  • Other concurrent endocrine therapy is allowed as follows:

    • Hormonal therapy (e.g., megestrol) for appetite stimulation
    • Nasal, ophthalmic, or topical glucocorticoids
    • Oral glucocorticoids for adrenal insufficiency
    • Low-dose maintenance steroids


  • See Disease Characteristics
  • At least 28 days since prior radiotherapy for the primary malignancy or metastases and recovered
  • No prior wide-field radiotherapy to 25% or more of marrow-bearing bone
  • No prior pelvic irradiation
  • No concurrent radiotherapy for the primary malignancy or metastases
  • No concurrent wide-field radiotherapy for pain management


  • See Disease Characteristics
  • Recovered from any prior surgery
  • No prior surgical procedures affecting absorption


  • No prior agent for the primary malignancy targeting the epidermal growth factor receptor (EGFR) or EGFR-specific tyrosine kinase activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033241

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229-3271
Sponsors and Collaborators
OSI Pharmaceuticals
National Cancer Institute (NCI)
Study Chair: Pedro Santabarbara, MD OSI Pharmaceuticals

Additional Information:
Publications of Results:
Dragovich T, Patnaik A, Rowinsky EK, et al.: A phase I B trial of gemcitabine and erlotinib HCL in patients with advanced pancreatic adenocarcinoma and other potentially responsive malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-895, 2003.

Responsible Party: OSI Pharmaceuticals Identifier: NCT00033241     History of Changes
Other Study ID Numbers: OSI-774-155
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc ( OSI Pharmaceuticals ):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
unspecified adult solid tumor, protocol specific
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors