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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J0386 | |||
| 04-02-20-03 | Other Identifier | JHM IRB | |
| ZENECA-IRUSIRES0304 | |||
| CDR0000549896 | Other Identifier | other |
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Closed due to early stopping rule-Low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, Cisplatin, ZD1839 and Radiotherapy | Experimental | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Cisplatin IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as Assessed by NCI CTC v2.0 | 5 years | |
| Safety and Tolerability of This Regimen | 5 years | |
| Time to Progression |
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Inclusion Criteria:
Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction meeting the following criteria:
Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy
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
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| Name | Affiliation | Role |
|---|---|---|
| Arlene A. Forastiere, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Posto ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adjuvant therapy: Combined Modality Paclitaxel, Cisplatin, |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| gefitinib |
| Drug |
Gefitinib IV |
|
|
| paclitaxel | Drug | Paclitaxel IV |
|
|
| adjuvant therapy | Procedure | Postoperative ZD1839 |
|
|
| radiation therapy | Radiation | Radiotherapy |
|
|
| 5 years |
| Survival | 5 years |
| Correlation Between EGFR Pathway Component Expression and Activation With Pathologic Complete Response and Survival | 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adjuvant therapy: Combined Modality Paclitaxel, Cisplatin, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Trial stopped due to early stopping rule, no data analysis completed. | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
| |||||||||||||||||||
| Secondary | Toxicity as Assessed by NCI CTC v2.0 | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
| ||||||||||||||||||||
| Secondary | Safety and Tolerability of This Regimen | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
| ||||||||||||||||||||
| Secondary | Time to Progression | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
| ||||||||||||||||||||
| Secondary | Survival | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
| ||||||||||||||||||||
| Secondary | Correlation Between EGFR Pathway Component Expression and Activation With Pathologic Complete Response and Survival | Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure | Posted | 5 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy | Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adj therapy: Combined Modality Paclitaxel, Cisplatin, | 0 | 19 | 0 | 19 |
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Study was closed due to early stopping rule.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rosalyn Juergens, MD. | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-908-7829 | rjuerge1@jhmi.edu |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077156 | Gefitinib |
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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