Esophageal CancerPhase 2NCT00003748
Irinotecan in Treating Patients With Esophageal or Stomach Cancer
A Phase 2 study testing irinotecan hydrochloride in people with Esophageal Cancer and Gastric Cancer, run by Jonsson Comprehensive Cancer Center at 25 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer. 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?
- irinotecan hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 1998to Jan 2005
- 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
- Patients must be > 18 years of age
- Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Patients must have a predicted life expectancy of at least 12 weeks
- Patients must have a pretreatment granulocyte count of >1500/mm3, a hemoglobin level of >9.0 gm/dL and the platelet count of >100000/mm3
- Patients must have adequate renal function as documented by a serum creatinine < 2.0 mg/dL
- Patients must have adequate hepatic function as documented by a serum bilirubin < 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase must be < 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be < 5 x institutional upper limit of normal
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- Patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy
- Patients must have disease radiologically measurable bidimensionally
- Patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy
Who cannot join
- Patients with any active or uncontrolled infection
- Patients with psychiatric disorders that would interfere with consent or follow-up
- Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy
- Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
- Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis
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- Patients with uncontrolled diabetes mellitus
- Patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Prior therapy with a deoxyribonucleic acid (DNA) topoisomerase inhibitor
- Patients with known Gilbert's syndrome
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
St Jude Heritage Health Foundation
Fullerton, California, 92835
Daniel Freeman Memorial Hospital
Inglewood, California, 90301
UCLA - Antelope Valley Cancer Center
Lancaster, California, 93534
Cancer Care Consultants
Las Vegas, Nevada, 89119
Pacific Shores Medical Group
Long Beach, California, 90813
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Community Hospital of the Monterey Peninsula
Monterey, California, 93940
Office of Jerome L. Rubin
Monterey, California, 93940
Office of Eddie Hu, M.D.
Monterey Park, California, 91754
Ventura County Hematology-Oncology Medical Group, Inc.
Oxnard, California, 93030
Wilshire Oncology Medical Center
Pomona, California, 91767
Salinas Valley Memorial Hospital
Salinas, California, 93901
Cancer Center of Santa Barbara
Santa Barbara, California, 93105
Sansum Medical Clinic
Santa Barbara, California, 93105
James L. Poth, M.D., Michael Alexander, M.D., Inc.
Santa Cruz, California, 95065
Marian Medical Center
Santa Maria, California, 93454
Office of Marilou Terpenning
Santa Monica, California, 90404
Office of Robert C. Klein
Santa Monica, California, 90404
Dominican and Watsonville Community Hospital
Soquel, California, 95073
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Cancer Care Associates Medical Group
Torrance, California, 90505
UCLA Cancer Center - Santa Clarita
Valencia, California, 91355
Oncology Medical Center of North County
Vista, California, 92083
Valley Hematology and Oncology
West Hills, California, 91307
About this study
Official title: Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
Read the detailed description
OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- irinotecan hydrochloride
- Keywords
- stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called CPT-11
One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| irinotecan hydrochloride | Experimental | One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. Receives: Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy
Measured: 2 years
Secondary outcomes (1)
Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startAug 1998
- Primary completionJun 2000
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia and Upjohn
- Responsible party
- Sponsor
- Investigators
- Joel R. Hecht, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003748
- Sponsor's protocol ID
- CDR0000066868
- Other IDs
- UCLA-HSPC-9703008, P-UPHJOHN-6475-96014, NCI-G99-1497
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 1999
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
- ClinicalTrials.gov ID
- NCT00003748
- Acronym / sponsor ID
- CDR0000066868
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pharmacia and Upjohn
- Study start
- Aug 1998
- Primary completion
- Jun 2000 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Jul 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
Detailed description
OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan hydrochloride | Experimental | Drug: irinotecan hydrochlorideOne course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be > 18 years of age
- Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Patients must have a predicted life expectancy of at least 12 weeks
- Patients must have a pretreatment granulocyte count of >1500/mm3, a hemoglobin level of >9.0 gm/dL and the platelet count of >100000/mm3
- Patients must have adequate renal function as documented by a serum creatinine < 2.0 mg/dL
Key exclusion criteria (10 listed)
- Patients with any active or uncontrolled infection
- Patients with psychiatric disorders that would interfere with consent or follow-up
- Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy
- Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
- Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
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 |
|---|---|---|
| irinotecan hydrochlorideAlso: CPT-11One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. | Drug | irinotecan hydrochloride |
Primary outcome
To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy
Time frame: 2 years
1 secondary outcome
Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
Time frame: 2 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 3 Aug 2020.
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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.
Joel R. Hecht, MD principal investigator
Jonsson Comprehensive Cancer Center
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride in people with Esophageal Cancer and Gastric Cancer, run by Jonsson Comprehensive Cancer Center at 25 sites 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 9 inclusion and 10 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy (time frame: 2 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 3 Aug 2020.