Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00003326|
Recruitment Status : Unknown
Verified April 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 20, 2004
Last Update Posted : July 24, 2008
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||May 20, 2004|
|Last Update Posted Date||July 24, 2008|
|Start Date ICMJE||September 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003326 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus|
|Official Title ICMJE||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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Esophageal Cancer|
|Intervention ICMJE||Drug: paclitaxel|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00003326|
|Other Study ID Numbers ICMJE||CDR0000066278
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Theradex|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||April 2001|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP