NCT00003427

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 1998

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

4 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

Anal CancerColorectal CancerEsophageal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerGastrointestinal Carcinoid TumorLiver CancerPancreatic CancerSmall Intestine Cancer

Keywords

stage IV colon cancerstage IV gastric cancerrecurrent gastric cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancerstage IV esophageal cancerrecurrent esophageal cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumoradvanced adult primary liver cancerrecurrent adult primary liver cancerunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage IV pancreatic cancer

Interventions

irinotecan hydrochlorideDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic gastrointestinal carcinoma Measurable disease No CNS metastases No obstruction or partial obstruction of GI tract No obstruction of genitourinary tract PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled high blood pressure, unstable angina, active congestive heart failure, myocardial infarction within prior 6 months, or serious uncontrolled cardiac arrhythmia Neurological: No concurrent symptomatic peripheral sensory neuropathy Other: No active or uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cisplatin, oxaliplatin, nitrosoureas, or mitomycin C 1 or 2 prior chemotherapy regimens allowed (including irinotecan) Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy to whole pelvis, 30% or greater of bone marrow, and site of measurable disease At least 4 weeks since prior radiation therapy and recovered Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Kemeny N, Tong W, Gonen M, Stockman J, Di Lauro C, Teitcher J, White P, Price C, Saltz L, Sharma S, Graham MA. Phase I study of weekly oxaliplatin plus irinotecan in previously treated patients with metastatic colorectal cancer. Ann Oncol. 2002 Sep;13(9):1490-6. doi: 10.1093/annonc/mdf247.

    PMID: 12196376RESULT

MeSH Terms

Conditions

Anus NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsLiver NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Hepatocellular

Interventions

IrinotecanOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Nancy E. Kemeny, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

April 1, 1998

Primary Completion

April 1, 2002

Study Completion

April 1, 2002

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

US(1)