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BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556

Phase 1
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

Thank you

Trial Information

BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556

The primary objective of this phase I study is to determine the safety, tolerability and
optimal tolerated regimen of GW572016 when combined with gemcitabine and with the
combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each
dose level to assess toxicity. To better assess the safety at the final dose level in both
Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for
both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated
on this study.

Trial finished and no further data will be collected.

Inclusion Criteria:

- 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.

A female is eligible to enter and participate in the study if she is of:

1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
including any female who:

- 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

- 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

- 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

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following
criteria apply:

- 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

- Malabsorption syndrome disease significantly affecting gastrointestinal function or
major resection of the stomach or small bowel that could affect absorption of

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary safety and tolerability

Principal Investigator

howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

December 2007

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms



Brown University Oncology GroupProvidence, Rhode Island  02912