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Esophageal CancerPhase 2NCT00258323

Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer

A Phase 2 study testing cisplatin, fluorouracil and Iressa in people with Esophageal Cancer, run by Case Comprehensive Cancer Center 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

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
cisplatin, fluorouracil and Iressa
How many people
80 participants
Where
1 siteUnited States
Study dates
Oct 2005to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction
  • T3, N1, or M1a disease only
  • The following types are not allowed:
  • Small cell undifferentiated carcinomas, lymphomas, or sarcomas
  • Small cell or mixed small cell/non-small cell histology
  • No evidence of distant hematogenous tumor metastases (M1b)
  • No malignant pleural effusions

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • No unstable or uncompensated hepatic disease

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Calcium normal
  • No unstable or uncompensated renal disease

Cardiovascular

  • No unstable or uncontrolled angina
  • No unstable or uncompensated cardiac disease

Pulmonary

  • See Disease Characteristics
  • No limitations to pulmonary function that would preclude study participation
  • No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed)
  • No unstable or uncompensated respiratory disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No evidence of severe or uncontrolled systemic disease
  • No other uncontrolled malignancy
  • No active infection
  • No known severe hypersensitivity to gefitinib or any of its excipients

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for this cancer

Chemotherapy

  • No prior chemotherapy for this cancer

Radiotherapy

  • No prior radiotherapy for this cancer

Surgery

  • Recovered from any prior oncologic or other major surgery
  • No prior surgical resection for this cancer
  • No concurrent ophthalmic surgery

Other

  • No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)
  • More than 30 days since prior unapproved or investigational drug
  • No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma

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

PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the activity of gefitinib, in terms of median survival and distant metastatic disease control, in patients treated with neoadjuvant and adjuvant cisplatin, fluorouracil, and radiotherapy who are undergoing surgery for esophageal and gastroesophageal junction cancer.

Secondary

  • Determine the pathologic complete and partial response rate in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients and in patients who are disease free and receiving long-term maintenance gefitinib.

OUTLINE:

  • Preoperative regimen: Patients undergo radiotherapy twice a day during days 1-12 (for a total of 10 treatment days). Patients receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4. Patients also receive oral gefitinib once daily on days 1-28. At 6 weeks, patients with locoregionally confined disease undergo surgical resection and then proceed to the postoperative regimen. Patients with a medical contraindication to surgery proceed directly to the postoperative regimen.
  • Postoperative regimen: Beginning 4-10 weeks after surgery or 6 weeks after completing the first course of therapy, patients undergo radiotherapy and receive fluorouracil and cisplatin as in the preoperative regimen.
  • Maintenance regimen: Patients receive oral gefitinib beginning on day 1 of the postoperative regimen and continuing for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Being tested
cisplatin, fluorouracil, Iressa, conventional surgery, radiation therapy
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • cisplatinDrug

    Also called CDDP

    20mg/m2d/IV continuous infusion x days

  • fluorouracilDrug

    Also called 5 FU

    1000mg/m2/d IV continuous infusion x 4 days

  • IressaDrug

    Also called ZD 1839

    250mg po qd days 1-28 then x 2 years

  • conventional surgeryProcedure or surgery

    conventional surgery

  • radiation therapyRadiation

    150 cGy bid

What is being measured

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

  1. Survival at 1 year

    Survival at 1 year

    Measured: 1 year

  2. Distant metastatic control at 1 year

    Distant metastatic control at 1 year

    Measured: 1 year

Secondary outcomes (3)

  1. Response rate at 6 weeks

    Response rate at 6 weeks

    Measured: 6 weeks

  2. Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks

    Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks

    Measured: 6 weeks

  3. Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy

    Toxicity of maintenance gefitinib as measured by CTC version 2.0

    Measured: 8 weeks

Timeline

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

  1. First posted24 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2007
  4. Study completionFeb 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00258323
Sponsor's protocol ID
CCF5848
Other IDs
P30CA043703, CCF-5848, ZENECA-1839/US/0233
Status last verified
Sep 2015
First submitted
22 Nov 2005
Last updated
30 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, fluorouracil and Iressa in people with Esophageal Cancer, run by Case Comprehensive Cancer Center 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?

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 30 Sep 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Survival at 1 year (time frame: 1 year). 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 NCT00258323.

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 30 Sep 2015.

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