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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006245
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: alvocidib Drug: paclitaxel Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer
Study Start Date : July 2000
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006245

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
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.

Layout table for additonal information Identifier: NCT00006245    
Other Study ID Numbers: CDR0000068176
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors