Esophageal CancerPhase 2NCT00003326
Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
A Phase 2 study testing paclitaxel in people with Esophageal Cancer, run by Theradex at 30 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 paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- paclitaxel
- How many people
- 100 participants
- Where
- 30 sitesUnited States
- Study dates
- Sep 1997to not given
- 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 proven metastatic, locally recurrent, or unresectable squamous cell carcinoma or adenocarcinoma of the esophagus The bulk of the tumor must involve the esophagus or gastroesophageal (GE) junction (for tumors extending between the GE junction into the proximal stomach) Gastric cancers with only minor GE junction or distal esophagus involvement are not eligible Measurable or evaluable disease No prior treatment for metastatic disease No brain metastases No osseous metastases as only site of disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No New York Heart Association class III/IV heart disease No myocardial infarction within 6 months of study No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurologic: No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection or medical illness No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No invasive malignancies within 5 years, except: Curatively treated basal or squamous cell carcinoma of the skin Curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study No concurrent immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen or chemotherapy/radiation therapy given in a neoadjuvant or adjuvant setting No prior chemotherapy within 4 weeks of study No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy within 4 weeks of study Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: No prior radiotherapy within 4 weeks of study No prior radiation to greater than 30% of bone marrow No more than 1 prior chemotherapy/radiation therapy regimen given in a neoadjuvant or adjuvant setting No concurrent radiotherapy Surgery: No prior surgery within 2 weeks of study Other: No prior parenteral antibiotics within 1 week of study
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Akron City Hospital
Akron, Ohio, 44309
Harrington Cancer Center
Amarillo, Texas, 79106
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
Lone Star Oncology
Austin, Texas, 78759
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Hollings Cancer Center
Charleston, South Carolina, 29403
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Florida Cancer Specialists
Fort Myers, Florida, 33901
Pitt County Memorial Hospital
Greenville, North Carolina, 27835-6028
Oncology Consultants
Houston, Texas, 77024
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
Nevada Cancer Center
Las Vegas, Nevada, 89109
Loma Linda University Medical Center
Loma Linda, California, 92354
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Missoula Medical Oncology P.C.
Missoula, Montana, 59802
Cancer Center of Southern Alabama
Mobile, Alabama, 36607
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Medicine and Dentistry of New Jersey - MOBILE
Newark, New Jersey, 07103
Rochester General Hospital
Rochester, New York, 14621
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Savannah Hematology Oncology Associates
Savannah, Georgia, 31405
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Memorial Hospital
Worcester, Massachusetts, 01605
About this study
Official title: A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer
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 paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.
Read the detailed description
OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life of these patients.
OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects is observed. Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years. Quality of life is assessed prior to treatment, prior to each course for 6 courses, then every 2 courses. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Esophageal Cancer
- Being tested
- paclitaxel
- Keywords
- stage IV esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2004 (estimated)
- Study startSep 1997
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.
- 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
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Paul Kelsen, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003326
- Sponsor's protocol ID
- CDR0000066278
- Other IDs
- THERADEX-B97-4250, BMS-TAX/MEN.04, MSKCC-98018, NYU-9801, NCI-V98-1414
- Status last verified
- Apr 2001
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00003326
- Acronym / sponsor ID
- CDR0000066278
- Conditions
- Esophageal Cancer
- Keywords
- stage IV esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Study start
- Sep 1997
- First posted
- 20 May 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 paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.
Detailed description
OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life of these patients.
OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects is observed. Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years. Quality of life is assessed prior to treatment, prior to each course for 6 courses, then every 2 courses. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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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 Paul Kelsen, MD study chair
Memorial Sloan Kettering Cancer Center
30 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 paclitaxel in people with Esophageal Cancer, run by Theradex at 30 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?
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: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Results are not available in the source record.
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 24 Jul 2008.