Esophageal NeoplasmsPhase 2NCT00054873
Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
A Phase 2 study testing tezacitabine and 5-fluorouracil in people with Esophageal Neoplasms and Stomach Neoplasms, run by Chiron Corporation at 29 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma
- What is being tested?
- tezacitabine and 5-fluorouracil
- How many people
- Not given
- Where
- 29 sitesUnited States
- Study dates
- Nov 2003to Dec 2004
- 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
- Males and females greater than or equal to 18 years of age.
- Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
- At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions.
- Karnofsky Performance Score greater than or equal to 70%.
- Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease.
- Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy.
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- Adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3.
- Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less than 5 X ULN
- Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/min.
- Both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center.
- Disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years.
Who cannot join
- Unstable angina or class III or IV New York Heart Association heart disease.
- CNS metastases.
- Pregnant or breast-feeding.
- Uncontrolled seizure disorder.
- Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea.
- Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less.
- Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. Concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0922
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology
Chicago, Illinois, 60611
The University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Denver VAMC
Denver, Colorado, 80220
Josephine Ford Cancer Center, Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Glendale Memorial Hospital
Glendale, California, 91204
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
The Sarah Cannon Cancer Center, Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Comprehensive Cancer Center at DRMC
Palm Springs, California, 92262
Desert Regional Medical Center
Palm Springs, California, 92262
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Sharp Clinical Oncology Research
San Diego, California, 92123
UCSF Comprehensive Cancer Center
San Francisco, California, 94115-1705
Cancer Institute Medical Group
Santa Monica, California, 90404
Swedish Cancer Institute
Seattle, Washington, 98104
LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology
Shreveport, Louisiana, 77130
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
ACRC/Arizona Clinical Research Center
Tucson, Arizona, 85712
Memorial Regional Comprehensive Cancer Center
Weston, Florida, 33326
About this study
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma
- Being tested
- tezacitabine, 5-fluorouracil
- Keywords
- Adenocarcinoma of the esophagus or stomach
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tezacitabineDrug
5-fluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2003 (estimated)
- Study startNov 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054873
- Sponsor's protocol ID
- TEZ001
- Status last verified
- Jun 2006
- First submitted
- 12 Feb 2003
- Last updated
- 11 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
- ClinicalTrials.gov ID
- NCT00054873
- Acronym / sponsor ID
- TEZ001
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma
- Keywords
- Adenocarcinoma of the esophagus or stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chiron CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Dec 2004
- First posted
- 13 Feb 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.
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females greater than or equal to 18 years of age.
- Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
- At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions.
- Karnofsky Performance Score greater than or equal to 70%.
- Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease.
Key exclusion criteria (7 listed)
- Unstable angina or class III or IV New York Heart Association heart disease.
- CNS metastases.
- Pregnant or breast-feeding.
- Uncontrolled seizure disorder.
- Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea.
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 |
|---|---|---|
| tezacitabine | Drug | – |
| 5-fluorouracil | Drug | – |
Primary outcome
Not reported in the source record.
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 Jul 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 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 tezacitabine and 5-fluorouracil in people with Esophageal Neoplasms and Stomach Neoplasms, run by Chiron Corporation at 29 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 11 inclusion and 7 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 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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.
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 Jul 2006.