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CompletedNCT00107341Updated Dec 13, 2016

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

A Phase 2 interventional study of bortezomib and carboplatin in Esophageal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • adenocarcinoma of the esophagus
  • stage IV esophageal cancer
  • recurrent esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 37 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    bortezomib + paclitaxel + carboplatin

    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.

    Drug: bortezomib · Drug: carboplatin · Drug: paclitaxel

Interventions

  • Drugbortezomib
  • Drugcarboplatin
  • Drugpaclitaxel
06

What researchers measure

Primary outcomes

  1. Confirmed tumor response rate

    Time frame: Up to 3 years

Secondary outcomes

  1. Time to tumor progression

    Time frame: Up to 3 years

  2. Overall survival

    Time frame: Up to 3 years

  3. Duration of response

    Time frame: Up to 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Jatoi 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. PubMed 20126980 ↗
  • Jatoi 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. PubMed 18449005 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00107341
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 6, 2005
Start date
Aug 2005
Primary completion
Feb 2007
Completion
May 2008
Last update
Dec 13, 2016

Study contacts

Aminah Jatoi, MD
study chair · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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