Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach

NCT00061932 | Completed Phase 2 Results DMC

• 2 other identifiers: NCI-2012-03015N01CM62204
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)

  CT or MRI imaging scans of measurable lesions were obtained at baseline and every 8 weeks thereafter. Responses were classified according to RECIST criteria (version 1.0)

  Up to 6 years

Secondary Outcomes (1)

• Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis

  Baseline to 6 years

Study Arms (2)

Stratum 1 (previously untreated)

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.

Drug: bortezomib; Drug: irinotecan

Stratum 2 (previously treated)

EXPERIMENTAL

(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.

Drug: bortezomib

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Stratum 1 (previously untreated); Stratum 2 (previously treated)

irinotecan DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, U-101440E

Stratum 1 (previously untreated)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the GE junction or stomach, which is beyond the scope of surgical resection
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• Patients may have received adjuvant therapy for resected disease
• Patients who have received no prior systemic therapy for advanced disease are eligible to receive PS341 + irinotecan
• Patients are eligible for PS-341 as a single agent if they have received any number of prior regimens for gastric cancer
• Life expectancy of greater than 6 weeks
• ECOG performance status =\< 2 (Karnofsky \>= 60%)
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>=100,000/uL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits
• When possible, patients will undergo an esophagogastroduodenoscopy (EGD) with biopsy prior to therapy then at 24 hours after starting PS-341
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents, concurrent radiation therapy, or other chemotherapy; patients who have had photodynamic therapy either within 4 weeks of study entry or concurrently are ineligible, unless it was used to relieve esophageal obstruction that could not be treated with laser, stent or dilatation
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS 341 or other agents used in the study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with PS341
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
• Patients with a concurrent malignancy are excluded (except for early stage squamous cell carcinoma of the skin or cervix which can be treated locally); patients with an advanced malignancy within the past five years are not eligible; patients with a prior malignancy who have been disease free for five years are eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

• Ocean AJ, Christos P, Sparano JA, Shah MA, Yantiss RK, Cheng J, Lin J, Papetti M, Matulich D, Schnoll-Sussman F, Besanceney-Webler C, Xiang J, Ward M, Dilts KT, Keresztes R, Holloway S, Chen EX, Wright JJ, Lane ME. Phase II trial of bortezomib alone or in combination with irinotecan in patients with adenocarcinoma of the gastroesophageal junction or stomach. Invest New Drugs. 2014 Jun;32(3):542-8. doi: 10.1007/s10637-014-0070-0. Epub 2014 Feb 15.

  PMID: 24526575 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Bortezomib; Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Results Point of Contact

• Title: Rutvi Patel
• Organization: Montefiore Medical Center

rupatel@montefiore.org

718-379-6861

Study Officials

• Allyson Ocean

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: April 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2013
• Last Updated: February 2, 2021
• Results First Posted: June 3, 2015

Record last verified: 2021-01

Locations

US (1)