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

A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00107341
Enrollment
37
Registered
2005-04-06
Start date
2005-08-31
Completion date
2008-05-31
Last updated
2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent esophageal cancer

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 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.

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 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.

Interventions

DRUGbortezomib
DRUGcarboplatin
DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Confirmed tumor response rateUp to 3 years

Secondary

MeasureTime frame
Time to tumor progressionUp to 3 years
Overall survivalUp to 3 years
Duration of responseUp to 3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026