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TerminatedNCT00290719Updated May 9, 2014

Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

A Phase 1 interventional study of cisplatin and gefitinib in Esophageal Cancer, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-09.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment

Why this study was terminated
low enrollment
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the pathologic response (complete and partial) in patients with resectable esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib, cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection.

Secondary

  • Assess the safety and toxicity of this regimen in these patients.
  • Evaluate objective tumor response in patients treated with this regimen.
  • Determine the rate of complete resection in patients treated with this regimen.
  • Determine surgical morbidity and mortality in patients treated with this regimen.

OUTLINE: This is an open-label study.

  • Induction phase: Patients receive oral gefitinib once daily on days 1-14. Patients with stable or responding disease proceed to neoadjuvant chemoradiotherapy.
  • Neoadjuvant chemoradiotherapy: Patients receive gefitinib as in the induction phase beginning in week 4 and continuing through the last day of radiotherapy. Patients also receive cisplatin IV over 1 hour and irinotecan hydrochloride IV over 30 minutes on days 22, 29, 43, and 50 and undergo radiotherapy once daily, 5 days a week, for 5 weeks (total of 25 doses).
  • Surgery: Within 4-8 weeks after completion of neoadjuvant chemoradiotherapy, patients with stable or responding disease undergo an esophagectomy and lymph node dissection. Patients with a progressive or unresectable disease are removed from the study.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 6 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus

    • AC of the gastroesophageal junction allowed

  • Tumor must be considered surgically resectable (T1-3, NX)

    • No early-stage cancer (T1, N0)

  • The following lymph node (LN) criteria are considered acceptable:

    • Regional thoracic LN metastases (N1)
    • LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan
    • Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan
  • No distant metastases (M0)

PATIENT CHARACTERISTICS:

  • Platelet count ≥ 100,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine clearance ≥ 50 mL/min
  • Creatinine serum level ≤ CTC grade 2
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST \< 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No known severe hypersensitivity to gefitinib or any of its excipients
  • No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease
  • No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina
  • No New York Heart Association class III or IV heart disease
  • No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation
  • No evidence of any significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for esophageal cancer
  • No prior radiotherapy that would overlap the study treatment fields
  • Recovered from prior major surgery
  • No nonapproved or investigational drugs within the past 30 days
  • No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

  • Drugcisplatin
  • Druggefitinib
  • Drugirinotecan hydrochloride
  • Procedureconventional surgery
  • Procedureneoadjuvant therapy
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Pathological response (complete and partial) post-operatively

Secondary outcomes

  1. Safety and toxicity post-operatively

  2. Response rate 2 weeks into treatment, pre-operatively, and post-operatively

  3. Completeness of resection post-operatively

  4. Surgical morbidity and mortality post-operatively

  5. Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment

07

Study locations

1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00290719
Lead sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 13, 2006
Start date
Nov 2005
Primary completion
Apr 2008
Completion
Jun 2008
Last update
May 9, 2014

Study contacts

Andrew Ko, MD
study chair · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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