Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT00026338 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 2, 2020
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer | Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride | Phase 3 |
OBJECTIVES:
- Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib.
- Compare the progression-free survival rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the response rate and response duration in patients treated with these regimens.
- Compare the nature, severity, and frequency of toxic effects of these regimens in these patients.
- Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens.
- Determine the pharmacokinetics of erlotinib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, extent of disease (locally advanced vs metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib once daily.
- Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent courses, at 4 weeks after study, and then every 12 weeks until disease progression.
Patients are followed at 4 weeks and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 11 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 569 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer |
| Actual Study Start Date : | October 29, 2001 |
| Actual Primary Completion Date : | September 17, 2004 |
| Actual Study Completion Date : | February 10, 2009 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: OSI-774 plus Gemcitabine |
Drug: erlotinib hydrochloride
150 mg po daily Drug: gemcitabine hydrochloride 1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle) |
| Active Comparator: Placebo plus gemcitabine |
Drug: gemcitabine hydrochloride
1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle) |
- Overall survival [ Time Frame: 3 years ]
- Progression free survival [ Time Frame: 3 years ]
- Quality of Life [ Time Frame: 3 years ]Canada, US and selected countries only
- Response rates [ Time Frame: 3 years ]Complete and partial response only.
- Toxicity [ Time Frame: 3 years ]
- EGFR levels [ Time Frame: 3 years ]Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
- Pharmacokinetics [ Time Frame: 3 years ]To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or metastatic disease that is considered unresectable
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine less than 1.5 times ULN
Cardiovascular:
- No uncontrolled high blood pressure
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past year
- No cardiac ventricular arrhythmias requiring medication
Gastrointestinal:
- No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
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No post-surgical malabsorption characterized by:
- Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR
- Requires IV hyperalimentation
- Pancreatic enzyme supplementation allowed provided that the above criteria are not met
Ophthalmic:
- No ocular inflammation or infection unless fully treated prior to study
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No significant ophthalmologic abnormalities, including the following:
- Severe dry eye syndrome
- Sjogren's syndrome
- Keratoconjunctivitis sicca
- Severe exposure keratopathy
- Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No serious active infection
- No other serious underlying medical, psychological, or geographical condition that would preclude study participation
- No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib
- No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy or immunotherapy
Chemotherapy:
- No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Chemotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Prior radiotherapy for local disease allowed if evidence of disease progression has occurred
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
- No concurrent ophthalmic surgery
Other:
- No prior epidermal growth factor receptor inhibitors
- At least 2 weeks since prior investigational drug
- No other concurrent investigational drugs during and for at least 30 days after study
- No other concurrent anti-cancer therapy
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 ClinicalTrials.gov identifier (NCT number): NCT00026338
Show 173 study locations
| Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Other Publications:
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00026338 |
| Other Study ID Numbers: |
PA3 CAN-NCIC-PA3 ( Other Identifier: PDQ ) OSI-CAN-NCIC-PA3 ( Other Identifier: OSI ) CDR0000069020 ( Other Identifier: PDQ ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | April 2, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Erlotinib Hydrochloride Antimetabolites, Antineoplastic |
Antimetabolites 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 |