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Pancreatic CancerPhase 2NCT00313560

ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)

A Phase 2 study testing erlotinib hydrochloride in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib in combination with standard adjuvant chemoradiation and chemotherapy in patients with resected adenocarcinoma of the pancreas. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
erlotinib hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
16 Mar 2006to 27 Feb 2019
Phase
Phase 2
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1) and a candidate to receive postoperative adjuvant chemoradiation. R2 (laparoscopic resection) based on the surgeons operative note will be excluded from the study.
  • Aged 18 years or older.
  • ECOG performance status < 1.
  • The effects of Erlotinib and Capecitabine 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) 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.
  • Patients must have normal organ and marrow function.
  • Provision of written informed consent
  • Patients must have a working knowledge of English in order to complete the quality of life questionnaires. Patients that do not meet this requirement will be exempt from the QoL assessment, but remain eligible for all other components of the study.

Who cannot join

  • Known severe hypersensitivity to Erlotinib any of the excipient of this product. Hypersensitivity to Capecitabine, doxifluridine, or 5-FU.
  • Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, non-invasive early stage bladder cancer (<T1), and cervical cancer in situ.
  • 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.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort. Careful monitoring of PT/INR must be done for patients taking Warfarin.
  • Incomplete healing from previous oncologic or other major surgery.
  • Gastrointestinal tract disease resulting in an inability to take oral medication.
Show all 11Show fewer
  • Pregnant women are excluded from this study because Erlotinib is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Erlotinib, breastfeeding should be discontinued if the mother is treated with Erlotinib. Capecitabine is also potentially teratogenic and its metabolites can be found in breast milk.
  • Patients with known AIDS or who are HIV-positive on anti-retroviral therapy are excluded since patients' immune deficiency are at increased risk of lethal infection when treated with marrow-suppressive therapy, and interactions between Erlotinib and anti-retroviral therapy are unknown. If patients have known risk factors of HIV they should be tested based on the discretion of the treating oncologist.
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
  • Previous radiation to the abdomen.
  • Previous chemotherapy for pancreatic cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: Phase II Study of Erlotinib (TarcevaTM) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer

To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib in combination with standard adjuvant chemoradiation and chemotherapy in patients with resected adenocarcinoma of the pancreas.

Read the detailed description

This study is a phase II trial of erlotinib in combination with chemoradiation in patients with stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation.

This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.

Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off) and External Beam Radiation Therapy (EBRT) to the tumor bed plus adjacent lymph nodes at doses of 50.4 Gy in 28 fractions after surgery. For patients with close or positive margins after resection, they will be able to receive 54.0 Gy over 30 fractions. Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus erlotinib 100 mg/daily.

Being tested
erlotinib hydrochloride
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II 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.

  • erlotinib hydrochlorideDrug

    Also called Tarceva

    Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)

Study groups in NCT00313560
Study groupRoleWhat they receive
Erlotinib and EBRT after pancreatectomyExperimentalAdjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg.
Receives: Drug: erlotinib hydrochloride

What is being measured

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

  1. Recurrence Free Survival

    Time from surgery to recurrence

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Number of Participants Experiencing Adverse Events

    Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile.

    Measured: up to 3 years

  2. Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)

    Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration [baseline (BL)], between completion of CRT and starting maintenance chemotherapy [time 1 (t1)], and within 3 months after completion of maintenance chemotherapy [time 2 (t2)]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.

    Measured: Up to 3 months after completion of maintenance chemotherapy

  3. Change in QoL as Assessed by QLQ-PAN 26

    Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline [BL]), between completion of CRT and starting maintenance chemotherapy (time 1 [t1]), and within 3 months after completion of maintenance chemotherapy (time 2 [t2]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome.

    Measured: 3 months

  4. Time to Death as Assessed by Median Overall Survival (Months)

    Measured: up to 5 years

Timeline

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

  1. First posted12 Apr 2006 (estimated)
  2. Study start16 Mar 2006
  3. Primary completion27 Dec 2013
  4. Study completion27 Feb 2019

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313560
Sponsor's protocol ID
J0534
Other IDs
R01CA104900, P30CA006973, NA_00025965, JHOC-05080408, GENENTECH-JHOC-J0534, CDR0000465208
Status last verified
Oct 2019
First submitted
11 Apr 2006
Last updated
4 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data is not intended to be shared with other researchers, although summary of findings will be made available. In the event individual participant data is requested as support for the summary data, this data will be made available following confirmation that all patient identifiers have been "de-identified"

Publications

  • Herman JM, Fan KY, Wild AT, Hacker-Prietz A, Wood LD, Blackford AL, Ellsworth S, Zheng L, Le DT, De Jesus-Acosta A, Hidalgo M, Donehower RC, Schulick RD, Edil BH, Choti MA, Hruban RH, Pawlik TM, Cameron JL, Laheru DA, Wolfgang CL. Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2013 Jul 15;86(4):678-85. doi: 10.1016/j.ijrobp.2013.03.032.

    PubMed 23773391

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 4 Jun 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Oct 2019). 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?

Recurrence Free Survival (time frame: Up to 3 years). 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 NCT00313560, which also lists 1 linked publication.

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 4 Jun 2020.

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