A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

NCT00439179 | Completed Phase 1 Results DMC

• 1 other identifier: BrUOG-PA-205
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients Who Experienced a Partial Response

  every two months until progression

Study Arms (4)

Cohort 1

EXPERIMENTAL

Weekly gem + GW572016, 1000mg/day (combination)

Drug: cohort 1

Cohort 2

EXPERIMENTAL

Weekly gem + GW572016, 1500 mg/day (combination)

Drug: cohort 2

cohort 3

EXPERIMENTAL

GEMOX + GW572016 1000 mg/day (combination)

Drug: cohort 3

cohort 4

EXPERIMENTAL

GEMOX + GW572016 1500 mg/day (combination)

Drug: cohort 4

Interventions

cohort 1 DRUG

Weekly gem + GW572016, 1000mg/day (combination)

Cohort 1

cohort 2 DRUG

Weekly gem + GW572016, 1500 mg/day (combination)

Cohort 2

cohort 3 DRUG

GEMOX + GW572016 1000 mg/day (combination)

cohort 3

cohort 4 DRUG

GEMOX + GW572016 1500 mg/day (combination)

cohort 4

Eligibility Criteria

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

You may qualify if:

• 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:
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Brown University Oncology Research Group

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

KPNA1 protein, human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

Hsafran@lifespan.org

4018633000

Study Officials

• howard Safran, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: July 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 17, 2020
• Results First Posted: May 5, 2014

Record last verified: 2020-02

Locations

US (1)