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

NCT00493025 | Terminated Phase 2 Results

• 6 other identifiers: J0386P30CA006973JHOC-J038604-02-20-03ZENECA-IRUSIRES0304CDR0000549896
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (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

  5 years

Secondary Outcomes (5)

• Toxicity as Assessed by NCI CTC v2.0

  5 years

• Safety and Tolerability of This Regimen

  5 years

• Time to Progression

  5 years

• Survival

  5 years

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

  5 years

Study Arms (1)

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

EXPERIMENTAL

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

Drug: cisplatin; Drug: gefitinib; Drug: paclitaxel; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

cisplatin DRUG

Cisplatin IV

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

gefitinib DRUG

Gefitinib IV

Also known as: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

paclitaxel DRUG

Paclitaxel IV

Also known as: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

adjuvant therapy PROCEDURE

Postoperative ZD1839

Also known as: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

radiation therapy RADIATION

Radiotherapy

Also known as: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Cisplatin; Gefitinib; Paclitaxel; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

Study was closed due to early stopping rule.

Results Point of Contact

• Title: Rosalyn Juergens, MD.
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

rjuerge1@jhmi.edu

410-908-7829

Study Officials

• Arlene A. Forastiere, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: April 1, 2005
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-11

Locations

US (1)