Esophageal CancerPhase 2NCT00004127
Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Esophageal Cancer and Gastric Cancer, run by University of Chicago at 22 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have… 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?
- FOLFOX regimen, fluorouracil and leucovorin calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Feb 2000to Aug 2003
- 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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia Stage IV or recurrent Bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT less than 2 times upper limit of normal (ULN) Renal: BUN less than 1.5 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure No unstable angina pectoris No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics appropriate for study No uncontrolled concurrent illness No active infection No clinical evidence of peripheral neuropathy by physical exam or history
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors during the first course of study Chemotherapy: More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia No prior fluorouracil Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No other concurrent anticancer agents
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Columbia LaGrange Memorial Hospital
LaGrange, Illinois, 60525
Central Baptist Hospital
Lexington, Kentucky, 40503
Loyola University Medical Center
Maywood, Illinois, 60153
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
Puerto Rico1 site
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
Read the detailed description
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy. Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- FOLFOX regimen, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- stage IV gastric cancer, recurrent gastric 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.
FOLFOX regimenDrug
fluorouracilDrug
oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Oxaliplatin (85 mg/m2, day 1 of every 14 day cycle), Leucovorin (500 mg/m2, day 1 and 2 of every 14 day cycle), Fluorouracil (Bolus of 400 mg/m2 followed by 22 hr continuous infusion of 600 mg/m2 on days 1 and 2 of every 14 day cycle) Receives: Drug: FOLFOX regimen; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startFeb 2000
- Primary completionOct 2002
- Study completionAug 2003
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 University of ChicagoThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann M. Mauer, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004127
- Sponsor's protocol ID
- 10015
- Other IDs
- UCCRC-10015, NCI-T99-0010
- Status last verified
- Feb 2013
- First submitted
- 10 Dec 1999
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
- ClinicalTrials.gov ID
- NCT00004127
- Acronym / sponsor ID
- 10015
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Oct 2002 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 7 May 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
Detailed description
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy. Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: FOLFOX regimen, Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatinOxaliplatin (85 mg/m2, day 1 of every 14 day cycle), Leucovorin (500 mg/m2, day 1 and 2 of every 14 day cycle), Fluorouracil (Bolus of 400 mg/m2 followed by 22 hr continuous infusion of 600 mg/m2 on days 1 and 2 of every 14 day cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FOLFOX regimen | Drug | Arm A |
| fluorouracil | Drug | Arm A |
| leucovorin calcium | Drug | Arm A |
| oxaliplatin | Drug | Arm A |
Primary outcome
Clinical response rate
Time frame: 3 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 11 Feb 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.
Ann M. Mauer, MD study chair
University of Chicago
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Esophageal Cancer and Gastric Cancer, run by University of Chicago at 22 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?
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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Puerto Rico. 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?
Clinical response rate (time frame: 3 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 11 Feb 2013.