|
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical research trials and PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus clinical trial. Subjects often receive the most expert healthcare possible for their PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus  PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
For Condition: recurrent esophageal cancer,squamous cell carcinoma of the esophagus,stage 3 esophageal cancer,Quality of Life,Adenocarcinoma of the Esophagus,stage 4 esophageal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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 PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus.
Details: OBJECTIVES: I. Determine the antitumor activity and duration of activity of PNU-93914 in patients with locally advanced or metastatic esophageal carcinoma. II. Determine the objective tumor response rate and tumor response duration in patients treated with this drug. III. Determine the survival of patients treated with this drug. IV. Determine the safety profile of this drug in these patients. V. Determine the effect of this drug on the quality of life of these patients. VI. Determine the time to tumor response, time to tumor progression, and time to treatment failure in patients treated with this drug. VII. Evaluate the change in dysphagia score in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive PNU-93914 IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course, and then at the final study visit. Patients are followed every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus; Tumors of the gastroesophageal junction allowed if at least 50% of the tumor involved the esophagus at time of initial diagnosis - Locally advanced or metastatic disease that is not amenable to surgery or radiotherapy with curative intent - Progressive disease after 1 chemotherapy regimen for locally advanced or metastatic disease; Relapse within 6 months of completing prior neoadjuvant chemotherapy allowed; Chemotherapy administered solely as a radiosensitizer not considered a prior chemotherapy regimen - At least 1 non-irradiated measurable target lesion; At least 20 mm in at least 1 dimension by conventional techniques OR At least 10 mm in at least 1 dimension by spiral CT scan - No known brain metastases, spinal cord compression, or carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent anticancer biologic response modifiers or immunotherapy; No concurrent sargramostim (GM-CSF); No concurrent prophylactic filgrastim (G-CSF) during first course of study - Chemotherapy: See Disease Characteristics; Recovered from prior chemotherapy; No prior taxane therapy; No other concurrent anticancer chemotherapy - Endocrine therapy: No concurrent anticancer hormonal therapy - Radiotherapy: See Disease Characteristics; Recovered from prior radiotherapy - Surgery: See Disease Characteristics; Recovered from prior surgery - Other: At least 4 weeks since prior investigational agent; No other concurrent investigational therapy; No concurrent participation in other clinical study No other concurrent antitumor therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present) - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No myocardial infarction within the past 6 months; No unstable angina; No New York Heart Association class III or IV heart disease; No severe uncontrolled cardiac arrhythmia - Other: HIV negative; No active infection; No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, basal cell skin cancer, or squamous cell carcinoma of the head and neck within the past 3 years; No concurrent malignancies at other sites; No psychiatric or other disorder that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068614; NCI-G01-1946,MSKCC-00124,P-UPJOHN-914-ONC-0355-009
Study Start Date: December 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016900
Other Recurrent Esophageal Cancer Studies:
1. Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
2. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
4. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
5. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
Related Studies:
Other recurrent esophageal cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
|
|
|
|
|
|
|
|
