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

NCT00107341 | Completed Phase 2

• 3 other identifiers: NCCTG-N044BNCI-2012-02646CDR0000413896
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Confirmed tumor response rate

  Up to 3 years

Secondary Outcomes (3)

• Time to tumor progression

  Up to 3 years

• Overall survival

  Up to 3 years

• Duration of response

  Up to 3 years

Study Arms (1)

bortezomib + paclitaxel + carboplatin

EXPERIMENTAL

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

bortezomib DRUG

bortezomib + paclitaxel + carboplatin

carboplatin DRUG

bortezomib + paclitaxel + carboplatin

paclitaxel DRUG

bortezomib + paclitaxel + carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (2)

• 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.

  PMID: 20126980 BACKGROUND

• 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.

  PMID: 18449005 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Bortezomib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: August 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2008
• Last Updated: December 13, 2016

Record last verified: 2016-12