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

This study has been terminated.
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00447122
First received: March 12, 2007
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

Phase II study of lapatinib and gemcitabine for patients with metastatic pancreatic cancer.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: gemcitabine and Lapatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreatic Cancer: A Phase II Study #108181

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Number of Patients Who Survived at 4 Months: Overall Survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
Drug: gemcitabine and Lapatinib
Other Name: lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression

Detailed Description:

103 patients with advanced pancreatic cancer will receive gemcitabine 1 gm/m2/week for 3 weeks then 1 week off and lapatinib 1500 mg/day until progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
      • 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).
      • Vasectomy
  • Adequate hematologic function: ANC ≥ 1500/ul, platelets ≥ 100,000/ul. Adequate hepatic function with total bilirubin ≤ 2.0 mg/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).
  • Adequate renal function: creatinine ≤ 2.0 mg/dL
  • 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.
  • 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 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.
  • Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption of lapatinib.
  • Any unresolved bowel obstruction.
  • The patient has inadequate venous access in the clinical judgment of the investigator or designated clinical staff.
  • Patient is taking any medication on the prohibited medications list in
  • 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 lapatinib is not expected.
  • Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447122

Locations
United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Investigators
Principal Investigator: Howard Safran, MD Brown University Oncology Research Group
  More Information

No publications provided

Responsible Party: howard safran, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00447122     History of Changes
Other Study ID Numbers: BrUOG-PA-209
Study First Received: March 12, 2007
Results First Received: May 21, 2013
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014