NCT00003704

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Apr 1999

Typical duration for phase_1 cancer

Geographic Reach
2 countries

18 active sites

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, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2016

Conditions

Cancer

Keywords

stage III colon cancerstage III rectal cancerrecurrent colon cancerrecurrent rectal cancerrecurrent anal cancerstage IIIA anal cancerstage IIIB anal cancerstage III cervical cancerrecurrent cervical cancerstage III ovarian epithelial cancerrecurrent ovarian epithelial cancerstage III vulvar cancerrecurrent vulvar cancerstage III vaginal cancerrecurrent vaginal cancerstage III penile cancerrecurrent penile cancerstage III endometrial carcinomarecurrent endometrial carcinomastage III bladder cancerrecurrent bladder cancerstage III malignant testicular germ cell tumorstage III prostate cancerrecurrent prostate cancerrecurrent malignant testicular germ cell tumorovarian stromal cancerrecurrent urethral cancerdistal urethral cancerproximal urethral cancerstage III ovarian germ cell tumorrecurrent ovarian germ cell tumorfallopian tube cancerprimary peritoneal cavity cancerstage III uterine sarcomarecurrent uterine sarcomaborderline ovarian surface epithelial-stromal tumorovarian sarcoma

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Up to 3 years

Study Arms (1)

capecitabine + radiation

EXPERIMENTAL

This is a dose-escalation study of capecitabine. Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy. Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 5.5-6 weeks. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Drug: capecitabineRadiation: radiation therapy

Interventions

capecitabineDRUG
capecitabine + radiation
radiation therapyRADIATION
capecitabine + radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma located in the pelvis that is unresectable, incompletely resected, or locally recurrent Must be biopsy-proven or have radiological progression All disease must be encompassable within standard pelvic radiotherapy fields No evidence of metastatic disease outside of the planned radiotherapy field PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine clearance at least 30 mL/min Other: Must maintain adequate oral nutrition (i.e., at least 1200 calories estimated intake per day) No significant infection or other concurrent medical condition that would preclude study No significant nausea or vomiting No malabsorption secondary to short-gut syndrome, Crohn's disease, or sprue No patients with more than 6 bowel movements per day or baseline no greater than grade 3 diarrhea for patients with colostomy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic cancer At least 6 months since prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: At least 21 days since prior laparotomy or laparoscopic procedure with or without resection Other: No concurrent sorivudine or chemically related analogues (e.g., brivudine)

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

Sponsors & Collaborators

Study Sites (18)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsRectal NeoplasmsAnus NeoplasmsUterine Cervical NeoplasmsCarcinoma, Ovarian EpithelialVulvar NeoplasmsVaginal NeoplasmsPenile NeoplasmsEndometrial NeoplasmsUrinary Bladder NeoplasmsTesticular NeoplasmsProstatic NeoplasmsUrethral NeoplasmsFallopian Tube Neoplasms

Interventions

CapecitabineRadiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAnus DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVulvar DiseasesVaginal DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesMale Urogenital DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesTesticular DiseasesProstatic DiseasesUrethral DiseasesFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTherapeutics

Study Officials

  • Charles Erlichman, MD

    Mayo Clinic

    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

November 1, 1999

First Posted

March 15, 2004

Study Start

April 1, 1999

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(17)CA(1)