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.
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
OBJECTIVES: Primary
- Determine the confirmed tumor response rate in patients with unresectable, metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with bortezomib, paclitaxel, and carboplatin.
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 neuropathy ≥ grade 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
- No prior immunotherapy for recurrent or metastatic disease
- No prior biologic therapy for recurrent or metastatic disease
- No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF])
Chemotherapy
- No prior chemotherapy for recurrent or metastatic disease
- Prior chemotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed
- Prior combination chemotherapy and radiotherapy allowed provided patient achieved a complete response AND the last dose of combination therapy was administered ≥ 6 months ago
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
- No prior radiotherapy for recurrent or metastatic disease
- Prior radiotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed
- No prior radiotherapy to > 25% of bone marrow for locally advanced disease
- More than 4 weeks since prior 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
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
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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