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Metastatic Pancreatic CancerPhase 1NCT00447122

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

A Phase 1 study testing Gemcitabine 1000mg/m2 30 minutes, Lapatinib 1000mg/d and Lapatinib 1500mg/d in people with Metastatic Pancreatic Cancer, run by Brown University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Gemcitabine 1000mg/m2 30 minutes, Lapatinib 1000mg/d and Lapatinib 1500mg/d
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Mar 2007to Aug 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lifespan Hospitals

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer: A Phase I Study #108181

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

Read the detailed description

To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer.

Being tested
Gemcitabine 1000mg/m2 30 minutes, Lapatinib 1000mg/d, Lapatinib 1500mg/d, Gemcitabine 1000mg/m2 100minutes, Oxaliplatin 100mg/m2
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine 1000mg/m2 30 minutesDrug

    Also called Gemzar

    1000mg/m2 30 minutes

  • Lapatinib 1000mg/dDrug

    Also called Tykerb, Tyverb

    1000mg/d

  • Lapatinib 1500mg/dDrug

    Also called Tykerb, Tyverb

    1500mg/d

  • Gemcitabine 1000mg/m2 100minutesDrug

    Also called Gemzar

    1000mg/m2 100minutes

  • Oxaliplatin 100mg/m2Drug

    Also called Eloxatin

    100mg/m2

Study groups in NCT00447122
Study groupRoleWhat they receive
treatment 1ExperimentalGemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks
Receives: Drug: Gemcitabine 1000mg/m2 30 minutes; Drug: Lapatinib 1000mg/d
treatment 2ExperimentalGemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks
Receives: Drug: Gemcitabine 1000mg/m2 30 minutes; Drug: Lapatinib 1500mg/d
treatment 3Experimentalgemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d
Receives: Drug: Lapatinib 1000mg/d; Drug: Gemcitabine 1000mg/m2 100minutes; Drug: Oxaliplatin 100mg/m2
treatment 4Experimentalgemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d
Receives: Drug: Lapatinib 1500mg/d; Drug: Gemcitabine 1000mg/m2 100minutes; Drug: Oxaliplatin 100mg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival for Patients With Metastatic Pancreatic Cancer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

Why it stopped: slow enrollment and lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447122
Sponsor's protocol ID
BrUOG-PA-209
Status last verified
Jan 2022
First submitted
12 Mar 2007
Last updated
8 Mar 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine 1000mg/m2 30 minutes, Lapatinib 1000mg/d and Lapatinib 1500mg/d in people with Metastatic Pancreatic Cancer, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival for Patients With Metastatic Pancreatic Cancer. (time frame: Date of study entry until the date of death, up to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.

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