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Gastroesophageal AdenocarcinomaPhase 2NCT01182610

Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

A Phase 2 study testing Panitumumab, Paclitaxel and Carboplatin in people with Gastroesophageal Adenocarcinoma and Adenocarcinoma of the Distal Esophagus, run by Accelerated Community Oncology Research Network 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

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Panitumumab, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Apr 2011to Mar 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy-proven adenocarcinoma of the distal esophagus, gastroesophageal junction, or proximal stomach (within 5cm of gastroesophageal junction)
  • No prior treatment for this disease
  • AJCC (American Joint Committee on Cancer) clinical stage II to IVA, potentially resectable disease
  • Measurable disease per RECIST 1.0 criteria
  • Medically fit for surgery; surgical consultation is encouraged prior to initiation of treatment
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
Show all 12Show fewer
  • Male or female; aged equal to or greater than 18 years
  • Life expectancy of greater than 3 months
  • Good organ, metabolic, bone marrow, and pulmonary function as specified in the protocol
  • Functioning central venous access device prior to treatment initiation
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
  • Ability to understand and the willingness to sign a written IRB (Institutional Review Board) approved informed consent

Who cannot join

  • Prior treatment for this disease
  • History of another primary cancer except curatively treated in situ cervical cancer, curatively resected nonmelanoma skin cancer, or other primary solid tumor curatively treated with no active disease present and no treatment administered for at least 5 years prior to enrollment
  • History or known presence of central nervous system metastases
  • History of allergic reactions attributed to compounds similar chemical or biologic composition to panitumumab, paclitaxel, carboplatin, or 5FU
  • Prior anti-EGFr-antibody therapy or treatment with small molecule EGFr inhibitors
  • Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies within 30 days prior to enrollment
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  • Chronic use of immunosuppressive agents with the exception of corticosteroids
  • Any investigational agent or therapy within 30 days prior to enrollment
  • 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
  • History of interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
  • History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the results
  • Unwilling or unable to comply with study requirements
  • Female who tests positive for serum or urine pregnancy test or is breast feeding
  • Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
  • Major surgery within 28 days or minor surgery within 7 days prior to treatment. Placement of a central venous access device less than one day prior to treatment start
  • Male or female of childbearing potential (women who are post-menopausal less than 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
  • Arterial ischemic event (myocardial infarction, stroke) within 3 months prior to enrollment
  • Ongoing therapeutic anticoagulation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

Other trials in United States

About this study

Official title: A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

Being tested
Panitumumab, Paclitaxel, Carboplatin, 5FU

What participants receive

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

  • PanitumumabDrug

    Also called Vectibix

    Panitumumab 9mg/kg on Days 1, 22, and 43

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 200mg/m2 on Days 1 and 22

  • CarboplatinDrug

    Also called Paraplatin, CBDCA

    Carboplatin AUC=6 on Days 1 and 22

  • 5FUDrug

    Also called 5-fluorouracil

    5FU 225mg/m2/day on Days 1-15 and 22-36

Study groups in NCT01182610
Study groupRoleWhat they receive
Treatment groupExperimentalPanitumumab 9mg/kg on Days 1, 22, and 43 Paclitaxel 200mg/m2 on Days 1 and 22 Carboplatin AUC=6 on Days 1 and 22 5FU 225mg/m2/day on Days 1-15 and 22-36
Receives: Drug: Panitumumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: 5FU

What is being measured

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

  1. Response Rate

    The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.

    Measured: From the start of study treatment until restaging evaluation performed between days 36 to 43

Secondary outcomes (4)

  1. Pathologic Response Rate

    The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H\&E) examination.

    Measured: At time of surgery (between days 50 to 64)

  2. Resection Rate of Surgery

    The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H\&E)examination, and the operative report indicates complete resection with no residual disease.

    The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H\&E) examination, and the operative report indicates complete resection with no residual disease.

    The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease.

    Measured: At time of surgery (between days 50 to 64)

  3. Thirty-day Surgical Mortality

    All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.

    Measured: From date of surgery to 30 days after date of surgery

  4. Survival

    Measured: 2-year survival from first dose of panitumumab

Timeline

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

  1. First posted17 Aug 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Safety concern in a similar trial enrolling the same patient population

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01182610
Sponsor's protocol ID
ACORN ARCHESO0611
Status last verified
Nov 2012
First submitted
13 Aug 2010
Last updated
3 Dec 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab, Paclitaxel and Carboplatin in people with Gastroesophageal Adenocarcinoma and Adenocarcinoma of the Distal Esophagus, run by Accelerated Community Oncology Research Network 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 12 inclusion and 18 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 3 Dec 2012. 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 28 Nov 2012). 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?

Response Rate (time frame: From the start of study treatment until restaging evaluation performed between days 36 to 43). 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 NCT01182610.

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 3 Dec 2012.

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