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

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ClinicalTrials.gov Identifier: NCT00006245
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 11, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE July 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
Official Title  ICMJE Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Drug: alvocidib
  • Drug: paclitaxel
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006245
Other Study ID Numbers  ICMJE CDR0000068176
MSKCC-00060
NCI-1672
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP