NCT00066625

Brief Summary

Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in treating patients who have metastatic or unresectable cancer. Drugs used in chemotherapy such as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

August 6, 2003

Last Update Submit

January 31, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Probability of dose escalation according to true dose limiting toxicity (DLT) rate, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 28 days

Secondary Outcomes (3)

  • Area under the curve (AUC) estimates

    Days 1 and 15 (course 1)

  • Pharmacodynamic assessments (20S proteasome inhibition data)

    Days 1 and 15 (course 1)

  • Sequence of drug administration in terms of PK interaction

    Days 1 and 15 (course 1)

Study Arms (1)

Treatment (oxaliplatin, bortezomib)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and bortezomib IV over 3-5 seconds on days 1, 4, 15, and 18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and bortezomib until the MTDs are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Drug: oxaliplatinDrug: bortezomibOther: laboratory biomarker analysisOther: pharmacological study

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (oxaliplatin, bortezomib)
bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (oxaliplatin, bortezomib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (oxaliplatin, bortezomib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (oxaliplatin, bortezomib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignancy for which standard curative or palliative measures do not exist or are no longer effective
  • Metastatic or unresectable disease
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100
  • More than 6 months
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • AST and ALT no greater than 5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

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

Location

MeSH Terms

Interventions

OxaliplatinBortezomib

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Howard Hochster

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

July 1, 2003

Primary Completion

April 1, 2007

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)