Adenocarcinoma of the EsophagusPhase 2NCT00045526
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Esophagus and Adenocarcinoma of the Gastroesophageal Junction, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer
- What is being tested?
- erlotinib hydrochloride and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Feb 2007
- 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
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction
- Metastatic or surgically unresectable disease
- Measurable disease outside of primary tumor
- At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
- No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease
- No known brain metastases or carcinomatous meningitis
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- Must consent to having tumor tissue tested for epidermal growth factor receptor status
- Performance status-Karnofsky 70-100%
- Life expectancy of greater than 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) no greater than 2 times ULN
- Creatinine no greater than 1.5 mg/dL
- Calcium no greater than 12 mg/dL
- No symptomatic hypercalcemia
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No ventricular arrhythmia
- No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No other concurrent disease that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior cetuximab
- No more than 1 prior chemotherapy regimen for advanced or metastatic disease
- One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease
- At least 3 weeks since prior chemotherapy
- No concurrent investigational or commercial chemotherapy
- At least 3 weeks since prior radiotherapy
- No prior erlotinib-related compounds or compounds of similar biologic or chemical components
- No prior EGFR-targeting compounds (e.g., gefitinib)
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II Study Of OSI-774 In Advanced Esophageal Cancer
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride).
II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug.
IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Conditions
- Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer
- Being tested
- erlotinib hydrochloride, laboratory biomarker analysis
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (erlotinib hydrochloride) | Experimental | Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major response rate (complete and partial response)
Measured: Up to 5 years
Secondary outcomes (4)
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Measured: Up to 5 years
Degree of dysphagia relief
Measured: Up to 5 years
Time to progression
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Measured: Up to 5 years
Overall survival
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2002
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the EsophagusStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Ilson, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045526
- Sponsor's protocol ID
- NCI-2012-01418
- Other IDs
- 02-035, NSC-718781, NCI-5445, CDR0000256601, MSKCC-02035, N01CM62206
- Status last verified
- Jun 2013
- First submitted
- 6 Sep 2002
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of OSI-774 In Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00045526
- Acronym / sponsor ID
- NCI-2012-01418
- Conditions
- Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Feb 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride).
II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug.
IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (erlotinib hydrochloride) | Experimental | Drug: erlotinib hydrochloride, Other: laboratory biomarker analysisPatients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction
- Measurable disease outside of primary tumor
- No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease
- No known brain metastases or carcinomatous meningitis
- Must consent to having tumor tissue tested for epidermal growth factor receptor status
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given PO | Drug | Treatment (erlotinib hydrochloride) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (erlotinib hydrochloride) |
Primary outcome
Major response rate (complete and partial response)
Time frame: Up to 5 years
4 secondary outcomes
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time frame: Up to 5 years
Degree of dysphagia relief
Time frame: Up to 5 years
Time to progression
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ilson principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Esophagus and Adenocarcinoma of the Gastroesophageal Junction, run by National Cancer Institute (NCI) 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 37 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: finished, as of the sponsor's last update on 4 Jun 2013. 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?
Major response rate (complete and partial response) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2013.