Esophageal Cancer Clinical Trial
Official title:
Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer
Verified date | April 2004 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
United States,
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,
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