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Cancer of the EsophagusPhase 1/2POXXNCT00578071

Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer

A Phase 1/2 study testing Panitumumab, Capecitabine and Oxaliplatin in people with Cancer of the Esophagus, run by Brian Czito 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

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. Read more about this study

Who is it for?
Ages 18 to 82 years
Conditions the study is for
Cancer of the Esophagus
What is being tested?
Panitumumab, Capecitabine and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
Dec 2007to Jun 2012
Phase
Phase 1/2
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 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older.
  • Histologically or cytologically documented squamous cell carcinoma or Siewert's classification adenocarcinoma of the esophagus or proximal stomach T1-4, N0-2, M0-1, for which bimodality treatment with chemotherapy and radiation therapy is indicated.
  • Measurable Disease
  • ECOG Performance Status 0-1
  • Laboratory values must be as follows:
  • Absolute neutrophil count > or = 2,000/mm3,
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  • Platelets > or = 100,000/mm3,
  • Hemoglobin > 9.0,
  • Total bilirubin <1.5 x institutional upper normal limit,
  • Serum creatinine <1.5 x institutional upper normal limit,
  • AST or ALT < 3x institutional upper normal limit,
  • Magnesium equal or higher than institutional lower limit,
  • Creatinine clearance Estimated > 40 ml/min,
  • Calcium > lower limit of normal.
  • Not pregnant or lactating. Negative pregnancy test within 72 hours prior to registration (female patients of childbearing potential). Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Life expectancy must be >3 months.
  • No serious or poorly controlled medical or psychological conditions that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.
  • Able to swallow capecitabine (whole or crushed tablet or liquid dispersed) or patients may have a G or J tube.
  • No conditions that would significantly compromise intestinal absorption of the study drugs.

Who cannot join

  • Tumors extending above the level of the thoracic inlet or beyond 5 cm below the gastroesophageal junction.
  • Patients with radiographic or bronchoscopic evidence of esophageal perforation.
  • Patients with known evidence of brain metastases, lymphangitic lung metastases, or carcinomatous meningitis.
  • Dementia or significantly altered mental status
  • Major surgery within 4 weeks of the start of study treatment
  • Prior chemotherapy, radiation therapy, hormonal or biologic therapy within the past 6 months.
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  • Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids)
  • Currently requiring medications that may interact with the metabolism or disposition of capecitabine/5-FU: dipyridamole, folinic acid, allopurinol, trimethoprim, misonidazole, metoclopramide, flucytosine or cimetidine.
  • Hypersensitivity to platinum containing compounds or capecitabine or any of the excipients of this product. Prior unanticipated severe reaction to fluoropyrimidine/platinum therapy, or known sensitivity to 5-fluorouracil/platinum containing compounds.
  • Serious, uncontrolled, concurrent infection(s).
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  • Peripheral neuropathy > grade 1
  • Any of the following within 24 weeks before randomization: clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia).
  • Uncontrolled gastrointestinal ulcer within 28 days of randomization
  • History of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
  • Preexisting known bleeding diathesis or coagulopathy
  • Plans to continue on or use of ketoconazole, phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin or St. John's Wort, 14 days prior to randomization.
  • History of hypersensitivity to tetracyclines
  • Subject known to be human immunodeficiency virus positive
  • Subjects known to have chronic or active hepatitis B or C infection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin Chemotherapy With External Beam Radiation Therapy for the Treatment of Resectable, Locally Advanced/Unresectable or Metastatic Esophageal Cancer

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Read the detailed description

This study has a phase I/II design. For this study the administration of panitumumab is considered investigational.

Pretreatment: Part of regular cancer care and disease staging includes Chest/Abdomen CT Scan, upper endoscopic ultrasound, PET scan, J-Tube Placement (if clinically indicated), bronchoscopy (per clinician judgment), ECG, and baseline laboratory studies.

During Treatment Weeks 1-5.5 of Radiation Therapy(RT)/Chemotherapy:

  • RT (180 cGy/fx, Mon-Fri) days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38.
  • Panitumumab (per dose level) days 1, 15, 29.
  • Oxaliplatin (per dose level) days 1, 8, 15, 22, 29, 36.
  • Capecitabine (per dose level M-F) 1-5, 8-12, 15-19, 22-26, 29-33, 36-38.
Being tested
Panitumumab, Capecitabine, Oxaliplatin, Radiation Therapy (RT)
Keywords
esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • PanitumumabDrug

    Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.

  • CapecitabineDrug

    Also called Xeloda

    Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation

  • OxaliplatinDrug

    Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation

  • Radiation Therapy (RT)Radiation

    Daily for 6 weeks

Study groups in NCT00578071
Study groupRoleWhat they receive
TreatmentExperimentalpanitumumab, oxaliplatin, capecitabine and EBRT
Receives: Drug: Panitumumab; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiation Therapy (RT)

What is being measured

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

  1. Panitumumab Maximum Tolerated Dose in Milligrams (mg)

    Measured: 60 days

  2. Number of Participants With Dose-limiting Toxicities (DLTs)

    Measured: Within 30 days of the last day of radiation

Secondary outcomes (2)

  1. Overall Survival Rates for the Patients Studied on This Protocol.

    Number of patients alive one year after completing study protocol treatment.

    Measured: One year

  2. Pathological Complete Response Rates Associated With This Regimen.

    Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.

    Measured: 90 days

Timeline

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

  1. First posted20 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2011
  4. Study completionJun 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00578071
Sponsor's protocol ID
Pro00002207
Other IDs
SPS 151596
Acronym
POXX
Status last verified
May 2015
First submitted
18 Dec 2007
Last updated
2 Jul 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Panitumumab, Capecitabine and Oxaliplatin in people with Cancer of the Esophagus, run by Brian Czito 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 19 inclusion and 21 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 2 Jul 2015. 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 combined 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.

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 7 Aug 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?

Panitumumab Maximum Tolerated Dose in Milligrams (mg) (time frame: 60 days). The study lists 2 primary outcomes in all. 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 NCT00578071.

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 2 Jul 2015.

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