Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bortezomib + paclitaxel + carboplatin
- description
- 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.
- interventionNames
- Drug: bortezomib
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Confirmed tumor response rate
- timeFrame
- Up to 3 years
Secondary outcomes (3)
- measure
- Time to tumor progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (2)
- BACKGROUNDJatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535. PMID 20126980
- RESULTJatoi A, Dakhil SR, Foster NR, Ma C, Rowland KM Jr, Moore DF Jr, Jaslowski AJ, Thomas SP, Hauge MD, Flynn PJ, Stella PJ, Alberts SR. Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer: phase II results from the North Central Cancer Treatment Group (N044B). J Thorac Oncol. 2008 May;3(5):516-20. doi: 10.1097/JTO.0b013e31816de276. PMID 18449005