NCT00220649

Brief Summary

The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

First QC Date

September 16, 2005

Last Update Submit

August 14, 2009

Conditions

Pancreatic Neoplasms

Keywords

solid tumors or adenocarcinoma of the exocrine pancreas

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine

Secondary Outcomes (1)

  • To document any antitumor activity with biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine administered on this schedule

Interventions

gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists.
  • Age \> 18 years old.
  • A performance status of ≥ 60 on the Karnofsky scale
  • Life expectancy of at least 12 weeks.
  • Patients must give written informed consent as per institutional and federal regulatory requirements.
  • No chemotherapy, immunotherapy or radiotherapy for at least four weeks prior to entry in the study (six weeks for nitrosureas or mitomycin C). Patients may not receive concurrent chemotherapy, immunotherapy or radiotherapy while participating in this study. Patients may not receive concurrent treatment with any other investigational drug while on this protocol.
  • Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
  • Absolute granulocyte count of \> 1,500/mm3 and a platelet count \> 100,000/mm3.
  • Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dl, and a creatinine of ≤ 1.5 mg/dl respectively.
  • Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.
  • Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.
  • Patients must be disease-free of prior invasive malignancies for \>= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

You may not qualify if:

  • Individuals excluded from participating in this study are described below.
  • Women who are pregnant or breast-feeding
  • Patients with clinical signs of brain involvement or leptomeningeal disease.
  • Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus.
  • Patients with other serious illness or medical conditions, including but not limited to the following:
  • congestive heart failure or angina pectoris
  • previous history of myocardial infarction within 1 year from study entry
  • uncontrolled hypertension or arrhythmias
  • active infections
  • unstable diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineIrinotecanLeucovorinFluorouracilOxaliplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinonesCoordination ComplexesOrganic Chemicals

Study Officials

  • Peter Kozuch

    Continuum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2004

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

US(1)