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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

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.

Timeline

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

  1. First posted20 May 2004 (estimated)
  2. Study startSep 1997

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
Enrolment
100 participants (estimated)
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

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.

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