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

NCT00033241 | Completed Phase 1

• 4 other identifiers: OSI-774-155CDR0000069266UARIZ-HSC-01128NCI-V02-1694
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; unspecified adult solid tumor, protocol specific; stage IV pancreatic cancer

Interventions

erlotinib hydrochloride DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * 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) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * 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 Renal: * Creatinine less than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * 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 Gastrointestinal: * No significant gastrointestinal abnormalities including: * Requirement for IV alimentation * Active peptic ulcer disease Ophthalmic: * 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 Other: * 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy: * 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 Radiotherapy: * 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 Surgery: * See Disease Characteristics * Recovered from any prior surgery * No prior surgical procedures affecting absorption Other: * No prior agent for the primary malignancy targeting the epidermal growth factor receptor (EGFR) or EGFR-specific tyrosine kinase activity

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OSI Pharmaceuticals: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229-3271, United States

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Pedro Santabarbara, MD

  OSI Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: July 23, 2001
• Primary Completion: April 22, 2004
• Study Completion: April 22, 2004
• Last Updated: January 10, 2018

Record last verified: 2015-06

Locations

US (2)