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Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alvocidib
paclitaxel
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction If tumor extends below the GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction No gastric cancers with only a minor involvement of the GE junction or distal esophagus Metastatic or locally advanced disease that is considered surgically unresectable Must have failed a prior chemotherapy regimen that included paclitaxel for metastatic disease OR Failed prior combination taxane-based chemotherapy and radiotherapy for locally advanced disease Must have documented evidence of the following: Disease progression while on taxane-based neoadjuvant or adjuvant therapy OR Recurrent disease within 6 months of therapy Measurable disease Accurately measured in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan The following are considered nonmeasurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusions Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active angina or myocardial infarction within the past 6 months No significant ventricular arrhythmia requiring antiarrhythmic medication Atrial fibrillation that is well controlled on standard management allowed Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study No preexisting peripheral neuropathy of grade 2 or greater No serious concurrent infection No uncontrolled, nonmalignant medical illness that would preclude study HIV negative No other active malignancy within the past 5 years except: Nonmelanoma skin cancer or Carcinoma in situ of the cervix History of T1a or T1b prostate cancer (detected incidentally during transurethral resection of the prostate and comprising less than 5% of resected tissue) allowed if PSA normal since surgery No medical or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 6 months since prior paclitaxel No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed (indicator lesion must be outside of prior radiation port unless recent evidence of disease progression at that site) No concurrent radiotherapy Surgery: See Disease Characteristics Other: No prior cyclin-dependent kinase or protein kinase C inhibitors for esophageal cancer Recovered from toxic effects of any prior therapy No concurrent vitamins, antioxidants or herbal preparations or supplements

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
June 20, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006245
Brief Title
Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
Official Title
Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer that has not responded to previous paclitaxel therapy.
Detailed Description
OBJECTIVES: Determine the response rate in patients with paclitaxel-refractory locally advanced or metastatic esophageal cancer treated with sequential paclitaxel and flavopiridol. Determine the toxicity of this regimen in these patients. Assess the quality of life of patients treated with this regimen. Obtain pharmacokinetic information about this regimen. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and flavopiridol IV continuously over 24 hours on day 2 weekly for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after courses 1 and 2, and then every 2 courses thereafter. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alvocidib
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction If tumor extends below the GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction No gastric cancers with only a minor involvement of the GE junction or distal esophagus Metastatic or locally advanced disease that is considered surgically unresectable Must have failed a prior chemotherapy regimen that included paclitaxel for metastatic disease OR Failed prior combination taxane-based chemotherapy and radiotherapy for locally advanced disease Must have documented evidence of the following: Disease progression while on taxane-based neoadjuvant or adjuvant therapy OR Recurrent disease within 6 months of therapy Measurable disease Accurately measured in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan The following are considered nonmeasurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusions Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active angina or myocardial infarction within the past 6 months No significant ventricular arrhythmia requiring antiarrhythmic medication Atrial fibrillation that is well controlled on standard management allowed Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study No preexisting peripheral neuropathy of grade 2 or greater No serious concurrent infection No uncontrolled, nonmalignant medical illness that would preclude study HIV negative No other active malignancy within the past 5 years except: Nonmelanoma skin cancer or Carcinoma in situ of the cervix History of T1a or T1b prostate cancer (detected incidentally during transurethral resection of the prostate and comprising less than 5% of resected tissue) allowed if PSA normal since surgery No medical or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 6 months since prior paclitaxel No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed (indicator lesion must be outside of prior radiation port unless recent evidence of disease progression at that site) No concurrent radiotherapy Surgery: See Disease Characteristics Other: No prior cyclin-dependent kinase or protein kinase C inhibitors for esophageal cancer Recovered from toxic effects of any prior therapy No concurrent vitamins, antioxidants or herbal preparations or supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary K. Schwartz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Rathkopf DE, Ilson DH, Yi S, et al.: A phase II trial of sequential paclitaxel and flavopiridol in patients with metastatic paclitaxel-refractory esophageal cancer. [Abstract] American Society of Clinical Oncology 2004 Gastrointestinal Cancers Symposium, 22-24 January 2004, San Francisco, CA. A-67, 2004.
Results Reference
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Learn more about this trial

Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel

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