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Esophageal CancerPhase 2NCT00215995

Cisplatin and Irinotecan Chemotherapy, Followed by ZD 1839 (Iressa) in Patients With Esophageal or Gastric Carcinomas

A Phase 2 study testing Cisplatin, Irinotecan and ZD 1839 in people with Esophageal Cancer and Gastric Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in 2 countries.

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

This study is for patients with esophageal, esophagogastric, or gastric cancer that has spread to other parts of the body. The purpose of this study is to test the safety and effectiveness of a new experimental drug called ZD 1839 following initial therapy with two other chemotherapy drugs, called Irinotecan (CPT-11)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
Cisplatin, Irinotecan and ZD 1839
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesin 2 countries
Study dates
Jul 2003to May 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

  • Histologic confirmation of esophageal carcinoma (squamous or adenocarcinoma) or gastric adenocarcinoma.
  • Surgically unresectable disease and/or metastatic disease.
  • No prior chemotherapy therapy.
  • Life expectancy > 12 weeks.
  • Patients must have the ability to take and retain oral medications.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky Performance Status [KPS] ≥50%).
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  • Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and computerized tomographic scan performed within 28 days prior to registration.
  • Organ system function assessed within 7 days prior to registration and within the following parameters:
  • Absolute neutrophil count ≥1500/mL;
  • Platelet count ≥100,000/mL;
  • Hemoglobin level ≥10.0 gm/dL;
  • Serum creatinine ≤1.5 x IULN (Institutional Upper Limits of Normal); OR Measured creatinine clearance ≥60 mL/min;
  • AST (SGOT) or ALT (SGPT) ≤ 2.5 x IULN (unless the liver is involved by tumor, in which case it must be ≤5.0 x IULN);
  • Total bilirubin ≤1.5 x IULN.
  • Understanding of the subject of the potential and unknown teratogenic risk, as well as their willingness to practice birth control. Should a pregnancy occur while a subject, either father or mother, is receiving study medication, the subject should inform the doctor immediately.
  • Aged 18 years or older
  • Provision of written informed consent
  • For patients with locally advanced disease, subjects must be evaluated by a radiation oncologist prior to study entry, and judged that radiation therapy is not indicated in the subjects therapy.

Who cannot join

  • Prior treatment with EGFR-inhibiting agents, chemotherapy, or radiotherapy for esophagogastric carcinomas.
  • Patients must not be receiving any other investigational agents. Use of erythropoietin is allowable. Secondary prophylaxis with granulocyte colony stimulating factor (G-CSF) (Filgrastim) is allowable. The use of granulocyte-macrophage colony stimulating factor (GM-CSF) (Sargramostim) is not allowed on this protocol.
  • Uncontrolled brain metastases.
  • Patients must not have uncontrolled intercurrent illness at the time of registration including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients must not have current New York Heart Association Class III or IV heart disease.
  • Known human immunodeficiency virus (HIV) infection.
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  • Pregnant or breast-feeding women.
  • Patients who have had prior malignancies, except non-melanoma skin cancer (basal or squamous cell carcinoma) are not eligible for this study; unless greater than 5 years has passed since the event.
  • Known severe hypersensitivity to ZD 1839 or any of the excipients of this product.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
  • Incomplete healing from previous oncologic or other major surgery.
  • Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2.
  • Any evidence of clinically active interstitial lung disease. Subjects with chronic stable radiographic changes who are asymptomatic need not be excluded.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Puerto Rico2 sites

  • Ponce School of Medicine

    Ponce, 00732

  • University of Puetro Rico Cancer Center

    San Juan, 00936-5067

Other trials in Puerto Rico

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Study of Cisplatin and Irinotecan Induction Chemotherapy, Followed by ZD 1839 (IRESSA) in Adult Patients With Surgically Unresectable and/or Metastatic Esophageal or Gastric Carcinomas

This study is for patients with esophageal, esophagogastric, or gastric cancer that has spread to other parts of the body. The purpose of this study is to test the safety and effectiveness of a new experimental drug called ZD 1839 following initial therapy with two other chemotherapy drugs, called Irinotecan (CPT-11) and Cisplatin.

Read the detailed description

This is an open-label, non-randomized, multicenter Phase II study designed to evaluate tumor response rates in patients with surgically unresectable and/or metastatic esophageal, esophagogastric, and gastric adenocarcinoma or squamous carcinoma. Study schema is as follows. Patients will receive Irinotecan and Cisplatin on days 1 and 8 every 21 days for a maximum of 6 cycles of therapy. This is then followed by ZD 1839 (Iressa), which is an oral pill taken once daily. During the Iressa phase, patients will be evaluated every 6 weeks. This includes labs, CT scans and physical examination. The exploratory objective of the study is to examine the correlation between epidermal growth factor receptor (EGFR) expression and radiographic response to treatment.

Being tested
Cisplatin, Irinotecan, ZD 1839
Keywords
esophageal cancer, esophagogastric cancer, gastric cancer
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

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

  • CisplatinDrug

    Also called Platinol, Platinol-AQ

    As outlined in Detailed Description

  • IrinotecanDrug

    Also called Camptosar

    As outlined in Detailed Description

  • ZD 1839Drug

    Also called Iressa

    As outlined in Detailed Description

Study groups in NCT00215995
Study groupRoleWhat they receive
Cisplatin, Irinotecan and ZD1839ExperimentalAs outlined in Detailed Description.
Receives: Drug: Cisplatin; Drug: Irinotecan; Drug: ZD 1839

What is being measured

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

  1. Number of Participants With Desired Response

    Response rate

    Measured: 48 Months

Secondary outcomes (3)

  1. Duration of Participants' Desired Response

    Response duration in months

    Measured: 48 Months

  2. Participants' Time to Disease Progression

    Time to progression in months

    Measured: 48 Months

  3. Number of Participants With Overall Survival

    Overall survival from first participant On Treatment to last participant Off Study

    Measured: 48 Months

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionMay 2007
  4. Study completionMay 2007

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00215995
Sponsor's protocol ID
MCC-13426
Other IDs
USFIRB#101525
Status last verified
May 2007
First submitted
19 Sep 2005
Last updated
13 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Irinotecan and ZD 1839 in people with Esophageal Cancer and Gastric Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in 2 countries.

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 18 inclusion and 14 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 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Puerto Rico, 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?

Number of Participants With Desired Response (time frame: 48 Months). 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 NCT00215995.

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 13 Jan 2012.

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