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Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer


- 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

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-18

Inclusion Criteria


- 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

- 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

- 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



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3


- Bilirubin no greater than 1.5 mg/dL


- Creatinine no greater than 1.5 mg/dL


- 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


- 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


Biologic therapy:

- No concurrent immunotherapy


- See Disease Characteristics

- No more than 6 months since prior paclitaxel

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- 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


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

August 2007

Related Keywords:

  • Esophageal Cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021