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CompletedNCT00006245Updated Jun 24, 2013

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

A Phase 2 interventional study of alvocidib and paclitaxel in Esophageal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Esophageal Cancer

Keywords

  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

Browse Esophageal Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugalvocidib
  • Drugpaclitaxel
06

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
07

References and documents

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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006245
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Jul 2000
Completion
Aug 2007
Last update
Jun 24, 2013

Study contacts

Gary K. Schwartz, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2004. You cannot join it, but the record below documents what was studied.

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