NCT00055822

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. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. PURPOSE: Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or recurrent colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_1 colorectal-cancer

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

October 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

March 6, 2003

Last Update Submit

July 3, 2012

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonrecurrent colon cancerstage III colon cancerstage IV colon canceradenocarcinoma of the rectumrecurrent rectal cancerstage III rectal cancerstage IV rectal cancer

Interventions

oblimersen sodiumBIOLOGICAL
fluorouracilDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Unresectable, metastatic, or recurrent disease * Measurable or evaluable disease (phase I) * Measurable disease (phase II) * No known brain metastases * Patients with previously treated brain metastases who are not currently receiving steroids and have a stable CT scan or MRI are eligible PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * INR no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy) * PT/PTT no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy) Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reaction to compounds of similar chemical or biologic composition to fluorouracil or oxaliplatin * No other concurrent uncontrolled medical condition that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No known history of degenerative facet disease during prior fluorouracil therapy * No HIV-positive patients receiving combination antiretroviral therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent epoetin alfa during course 1 * No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent immunotherapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior oxaliplatin * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * Not specified Other * No prior oblimersen * No other concurrent investigational agents * No other concurrent antitumor therapy

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

Sponsors & Collaborators

Study Sites (1)

San Antonio Cancer Institute

San Antonio, Texas, 78229-3264, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

oblimersenFluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Anthony W. Tolcher, MD

    San Antonio Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

October 1, 2002

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

US(1)