BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer

NCT00447122 | Terminated Phase 1 Results DMC

• 1 other identifier: BrUOG-PA-209
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival for Patients With Metastatic Pancreatic Cancer.

  Date of study entry until the date of death, up to 12 months.

Study Arms (4)

treatment 1

EXPERIMENTAL

Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks

Drug: Gemcitabine 1000mg/m2 30 minutes; Drug: Lapatinib 1000mg/d

treatment 2

EXPERIMENTAL

Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks

Drug: Gemcitabine 1000mg/m2 30 minutes; Drug: Lapatinib 1500mg/d

treatment 3

EXPERIMENTAL

gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d

Drug: Lapatinib 1000mg/d; Drug: Gemcitabine 1000mg/m2 100minutes; Drug: Oxaliplatin 100mg/m2

treatment 4

EXPERIMENTAL

gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d

Drug: Lapatinib 1500mg/d; Drug: Gemcitabine 1000mg/m2 100minutes; Drug: Oxaliplatin 100mg/m2

Interventions

Gemcitabine 1000mg/m2 30 minutes DRUG

1000mg/m2 30 minutes

Also known as: Gemzar

treatment 1; treatment 2

Lapatinib 1000mg/d DRUG

1000mg/d

Also known as: Tykerb, Tyverb

treatment 1; treatment 3

Lapatinib 1500mg/d DRUG

1500mg/d

Also known as: Tykerb, Tyverb

treatment 2; treatment 4

Gemcitabine 1000mg/m2 100minutes DRUG

1000mg/m2 100minutes

Also known as: Gemzar

treatment 3; treatment 4

Oxaliplatin 100mg/m2 DRUG

100mg/m2

Also known as: Eloxatin

treatment 3; treatment 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 adenocarcinoma of the pancreas
• No prior chemotherapy for pancreatic cancer.
• ECOG performance status 0-1
• Must retain ability to swallow oral medications
• Age \> 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients \< 18 years of age, children are excluded from this study.
• Women of child bearing potential must be non pregnant and non lactating.The effects of lapatinib 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(demonstration of total cessation of menses for ³1 year).
• Childbearing potential, has a negative serum pregnancy test within 2 weeks prior to treatment to rule out pregnancy.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment.
• Intrauterine Device (IUD),
• Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.

You may not qualify if:

• Prior treatment with lapatinib or any EGFR targeting therapies.
• Prior treatment with systemic chemotherapy for pancreatic cancer.
• Clinical 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.
• Active cardiac disease, defined as:
• History of uncontrolled angina
• Myocardial infarction \< 6 months from study entry
• Uncontrolled or symptomatic congestive heart failure
• Ejection fraction below the institutional normal limit
• Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
• 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 lapatinib
• Participation in any investigational study within 28 days prior to study enrolment
• Any major surgery (insertion of a vascular access device or laparoscopy is not considered a major surgery), within the last 4 weeks.
• Pregnant or lactating females are excluded from this study because lapatinib 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 lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator
• Memorial Hospital of Rhode Island: collaborator

Study Sites (1)

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Lapatinib; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Organic Chemicals

Limitations and Caveats

Early termination due to slow enrollment and lack of funding.

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

BrUOG@brown.edu

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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 8, 2022
• Results First Posted: May 19, 2014

Record last verified: 2022-01

Locations

US (1)