NCT00004005

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2

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

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 26, 2017

Status Verified

October 1, 2011

Enrollment Period

7.1 years

First QC Date

November 1, 1999

Last Update Submit

April 24, 2017

Conditions

Carcinoma of Unknown PrimaryColorectal CancerUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

stage III colon cancerstage IV colon cancerstage III rectal cancerstage IV rectal cancerunspecified childhood solid tumor, protocol specificunspecified adult solid tumor, protocol specificadenocarcinoma of unknown primarynewly diagnosed carcinoma of unknown primaryrecurrent carcinoma of unknown primary

Outcome Measures

Primary Outcomes (3)

  • Response rate

  • Toxicity

  • Disease-free survival

Interventions

fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Histologically proven previously untreated stage III or stage IV colorectal carcinoma * Other carcinomas refractory to standard treatment * Metastatic adenocarcinoma of unknown primary site PATIENT CHARACTERISTICS: Age: * Under 25 Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Hemoglobin at least 10.0 g/dL * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Albumin greater than 3.0 g/dL * Bilirubin less than 1.5 mg/dL * SGOT or SGPT less than 2 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 80 mL/min * Urinalysis normal Other: * Blood glucose normal * Electrolytes normal * Prior curatively treated childhood cancer allowed * Weight greater than 10th percentile for height * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified 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)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms, Unknown PrimaryColorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

FluorouracilIrinotecanLeucovorinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesTherapeutics

Study Officials

  • Wayne Lee Furman, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1998

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 26, 2017

Record last verified: 2011-10

Locations

US(1)