A Trial Of GW572016, Gemcitabine And Oxaliplatin For Metastatic Pancreaticobiliary Cancer Schema

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-02-22	Results First Submitted 2013-05-13	Last Update Submitted that met QC Criteria 2020-02-13
First Submitted that Met QC Criteria 2007-02-22	Results First Submitted that Met QC Criteria 2014-04-03	Last Update Posted (ACTUAL) 2020-02-17
First Posted (ACTUAL) 2007-02-23	Results First Posted 2014-05-05	Last Verified 2020-02

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1 Weekly gem + GW572016, 1000mg/day (combination)	DRUG: cohort 1 Weekly gem + GW572016, 1000mg/day (combination)
EXPERIMENTAL: Cohort 2 Weekly gem + GW572016, 1500 mg/day (combination)	DRUG: cohort 2 Weekly gem + GW572016, 1500 mg/day (combination)
EXPERIMENTAL: cohort 3 GEMOX + GW572016 1000 mg/day (combination)	DRUG: cohort 3 GEMOX + GW572016 1000 mg/day (combination)
EXPERIMENTAL: cohort 4 GEMOX + GW572016 1500 mg/day (combination)	DRUG: cohort 4 GEMOX + GW572016 1500 mg/day (combination)

Primary Outcome Measures	Measure Description	Time Frame
Toxicity (Number of Patients Who Experiened DLTs)	To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs	until death, approximately 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Number of Patients Who Experienced a Partial Response	To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.	every two months until progression

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients are required to have histologically or pathologically confirmed, metastatic or locally advanced adenocarcinoma of the pancreas or biliary tree
No prior systemic chemotherapy for locally advanced or metastatic pancreaticobiliary cancer. No prior EGFR inhibitors.
ECOG performance status 0-2 retain ability to swallow oral medications
Age > 18, non pregnant. Because no dosing or adverse event data are currently available on the use of GW572016 in patients <18 years of age, children are excluded from this study.
The effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Has had a hysterectomy,
Has had a bilateral oophorectomy (ovariectomy),
Has had a bilateral tubal ligation, or
Is post-menopausal(a demonstration of total cessation of menses for ³1 year). 2. Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following:

Intrauterine Device (IUD),
Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
Complete abstinence from sexual intercourse for two weeks before exposure to investigational products, throughout the clinical trial, and for at least one week after the last dose of investigational product.
Double barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm)

Adequate hematologic function: ANC≥1500/ul,platelets≥100,000/ul,hemoglobin 8
Adequate hepatic function with total bilirubin ≤ 1.5mg/dL and ALT or AST ≤ 2x ULN. (Patients with liver metastases may have AST/ALT less than or equal to 5x upper limit of normal). Patients with elevated bilirubin secondary to biliary obstruction that have subsequently been stented may enter the protocol with a bilirubin of < 2.0 as long as the bilirubin is falling.
Adequate renal function: (creatinine ≤1.5mg/dL or estimated creatinine clearance greater than 60ml/min calculated by the Cockcroft Formula).
Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
No peripheral neuropathy for patients who receive oxaliplatin.
Life expectancy of at least 12 weeks
Signed informed consent

Prior treatment with GW572016 or any EGFR targeting therapies.
Prior treatment with systemic chemotherapy for metastatic pancreaticobiliary cancer.
Evidence of brain metastases or leptomeningeal disease
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known contraindications to the use of oxaliplatin or gemcitabine.
History of allergy to platinum compounds in patients receiving oxaliplatin. Amendment #2 4/28/05
The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016
Participation in any investigational study within 28 days prior to study enrolment
Any major surgery (insertion of a vascular access device is not considered a major surgery), hormonal therapy (other than replacement), chemotherapy or radiotherapy within the last 4 weeks and/or not recovered from prior therapy within the last 4 weeks and/or not recovered from prior therapy.
Pregnant or lactating females are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GW572016, breastfeeding should be discontinued if the mother is treated with GW572016.
Malabsorption syndrome disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption of GW572016.
Any unresolved bowel obstruction.
The patient has inadequate venous access in the clinical judgment of the investigator or designated clinical staff.
The patient is taking any medication on the prohibited medications list in Section 10.2 Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with GW572016 is not expected.
Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.

Collaborators and Investigators

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