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AzTrials

Esophageal CancerPhase 2NCT00493025

Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery

A Phase 2 study testing cisplatin, gefitinib and paclitaxel in people with Esophageal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cisplatin, gefitinib and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Apr 2005to Mar 2013
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction meeting the following criteria:
  • Newly diagnosed disease
  • Surgically resectable tumor
  • Primary esophageal tumor < 20 cm below the incisors
  • Tumor extending ≤ 2 cm into the cardia
  • Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy
Show all 32Show fewer
  • Documentation by endoscopic ultrasound, endoscopy, and CT scan of the chest and abdomen required
  • Any lesion suspicious for metastasis must be biopsied
  • M1a disease (i.e., celiac nodal metastasis) is allowed if other eligibility criteria are met
  • T4 disease (i.e., involvement of the pleura, pericardium, or diaphragm) allowed provided it is considered resectable
  • No CNS metastasis
  • ECOG performance status 0-1
  • Granulocyte count > 1,000/mm³
  • Platelet count > 75,000/mm³
  • Creatinine clearance > 60 mL/min
  • Total bilirubin < 1.5 mg/dL
  • No concurrent illness likely to preclude protocol therapy or surgical resection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy Exclusion Criteria
  • Known severe hypersensitivity to gefitinib or any of its excipients
  • Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Evidence of other significant clinical disorder or laboratory finding that would preclude study participation
  • Evidence of clinically active interstitial lung disease
  • Chronic, stable radiographic changes that are asymptomatic are eligible
  • Prior or concurrent malignancy except basal cell or squamous cell skin cancer, cervical cancer, or any other curatively treated malignancy from which the patient has been disease-free and has a survival prognosis of > 5 years
  • Preexisting peripheral neuropathy > grade 1
  • Incomplete healing from prior oncologic or other major surgery
  • Prior chemotherapy, radiotherapy, or surgery for this cancer
  • More than 30 days since prior nonapproved or investigational drugs
  • Concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
  • Concurrent oral retinoids

Who cannot join

None listed.

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 in Operable Adenocarcinoma of the Esophagus to Measure Response Rate and Toxicity of Preoperative Combined Modality Paclitaxel (Taxol®, Bristol-Myers Squibb), Cisplatin (Platinol®, Abbott Laboratories), ZD1839 (IRESSA®) and Radiotherapy Followed by Postoperative ZD1839

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving gefitinib after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving paclitaxel, cisplatin, gefitinib, and radiation therapy followed by surgery and gefitinib works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the pathologic complete response rate in patients with resectable, locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant paclitaxel, cisplatin, gefitinib, and radiotherapy followed by surgery and adjuvant gefitinib.

Secondary

  • Determine the survival of patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine time to disease progression in patients treated with this regimen.
  • Determine the plasma pharmacokinetics of unbound gefitinib in these patients.
  • Conduct exploratory studies to determine if EGFR pathway component expression and activation correlates with response to therapy and survival of these patients.
  • Determine if treatment with gefitinib alters the EGFR pathway in these patients.

OUTLINE: This is a prospective study.

  • Neoadjuvant therapy: Patients receive oral gefitinib beginning 14 days prior to the start of chemoradiotherapy and continuing until 7 days prior to surgery (10-12 weeks). Patients also receive paclitaxel IV over 1 hour and cisplatin IV over 2-3 hours on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks.
  • Surgery: Patients undergo surgical resection 4-6 weeks after the completion of neoadjuvant therapy.
  • Adjuvant therapy: Patients receive gefitinib once a day beginning 2-8 weeks after surgery and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

Blood samples are obtained at baseline and periodically during study for pharmacokinetic studies. Tumor tissue samples are obtained by core biopsy at baseline for biomarker correlative studies. Samples are analyzed by IHC to measure expression and activation of EGFR-signaling pathway biomarkers in pretreatment esophageal tumor tissue, including EGFR and phosphorylated (p)-EGFR, ERK and p-ERK, Akt and p-Akt, p70s6k and p-p70s6k, and p27.

After completion of study therapy, patients are followed periodically for at least 5 years.

Being tested
cisplatin, gefitinib, paclitaxel, adjuvant therapy, radiation therapy
Keywords
adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

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

  • cisplatinDrug

    Cisplatin IV

  • gefitinibDrug

    Also called Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

    Gefitinib IV

  • paclitaxelDrug

    Also called Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

    Paclitaxel IV

  • adjuvant therapyProcedure or surgery

    Also called Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

    Postoperative ZD1839

  • radiation therapyRadiation

    Also called Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

    Radiotherapy

Study groups in NCT00493025
Study groupRoleWhat they receive
Paclitaxel, Cisplatin, ZD1839 and RadiotherapyExperimentalPaclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839
Receives: Drug: cisplatin; Drug: gefitinib; Drug: paclitaxel; Procedure: adjuvant therapy; Radiation: radiation therapy

What is being measured

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

  1. Pathologic Complete Response Rate to the Neoadjuvant Regimen

    Study closed due to early stopping rule. Patient data was not analyzed. No additional information is available to report

    Measured: 5 years

Secondary outcomes (5)

  1. Toxicity as Assessed by NCI CTC v2.0

    Measured: 5 years

  2. Safety and Tolerability of This Regimen

    Measured: 5 years

  3. Time to Progression

    Measured: 5 years

  4. Survival

    Measured: 5 years

  5. Correlation Between EGFR Pathway Component Expression and Activation With Pathologic Complete Response and Survival

    Measured: 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 posted27 Jun 2007 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: Closed due to early stopping rule-Low accrual

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493025
Sponsor's protocol ID
J0386
Other IDs
P30CA006973, JHOC-J0386, 04-02-20-03, ZENECA-IRUSIRES0304, CDR0000549896
Status last verified
Nov 2018
First submitted
25 Jun 2007
Last updated
6 Dec 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, gefitinib and paclitaxel in people with Esophageal 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 32 inclusion and 0 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 6 Dec 2018. 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 6 Dec 2018). 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?

Pathologic Complete Response Rate to the Neoadjuvant Regimen (time frame: 5 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 NCT00493025.

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 6 Dec 2018.

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