Status:
COMPLETED
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the confirmed tumor response rate in patients with unresectable, metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00107341
Start Date
August 1 2005
End Date
May 1 2008
Last Update
December 13 2016
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