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Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction - Article


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Paclitaxel

Onxol; Taxol


Clinical Trial: Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction

This study is not yet open for patient recruitment.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable, metastatic cancer of the esophagus or gastroesophageal junction.

Condition Treatment or Intervention Phase
Adenocarcinoma of the Esophagus
stage IV esophageal cancer
recurrent esophageal cancer
 Drug: bortezomib
 Drug: carboplatin
 Drug: paclitaxel
 Procedure: chemotherapy
 Procedure: enzyme inhibitor therapy
Phase II

MedlinePlus related topics:  Esophageal Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bortezomib, Paclitaxel, and Carboplatin in Patients With Unresectable, Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Gastric Cardia

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the time to tumor progression, overall survival, and duration of response in patients treated with this regimen.
  • Determine the adverse events in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites:
  • Esophagus
  • Gastroesophageal junction
  • Gastric cardia
  • No greater than 2 cm from the gastroesophageal junction into the stomach
  • Unresectable, metastatic disease
  • Not a candidate for potentially curative therapy AND no other more reasonable potentially curative conventional therapy exists
  • At least 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
  • No known CNS metastases

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
  • No peripheral neuropathygrade 2
  • No uncontrolled infection
  • No chronic debilitating disease
  • No prior allergic reaction to carboplatin or paclitaxel
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • More than 4 weeks since prior open abdominal exploration (e.g., laparotomy)
  • More than 2 weeks since prior minimally invasive procedures (e.g., laparoscopy)

Location Information

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   
Cynthia X. Ma, MD, PhD,  Mayo Clinic Cancer Center   
Shaker R. Dakhil, MD, FACP,  CCOP - Wichita   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000413896; NCCTG-N044B
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  April 5, 2005
ClinicalTrials.gov Identifier:  NCT00107341
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: June 1, 2005
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