NCT00118300

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
Last Updated

July 8, 2011

Status Verified

July 1, 2011

First QC Date

July 8, 2005

Last Update Submit

July 7, 2011

Conditions

Cervical CancerEndometrial CancerOvarian CancerVaginal Cancer

Keywords

stage III cervical cancerstage IVA cervical cancerrecurrent cervical cancerstage III endometrial carcinomarecurrent endometrial carcinomastage III ovarian epithelial cancerrecurrent ovarian epithelial cancerstage III ovarian germ cell tumorrecurrent ovarian germ cell tumorstage III vaginal cancerstage IVA vaginal cancerrecurrent vaginal cancerovarian sarcomaovarian stromal cancerstage IV endometrial carcinomastage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage II vaginal cancerstage I vaginal cancer

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose

    weekly

  • Disease response measured prior to brachytherapy and at 1 month after completion of study treatment

    1 month after completion of study treatment

  • Toxicity as measured by CTC v 3.0 weekly

    weekly

Interventions

capecitabineDRUG

Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

brachytherapyRADIATION

1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)\* intracavitary brachytherapy once weekly in weeks 4-8.

radiation therapyRADIATION

Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed cervical cancer or other pelvic malignancy, including vaginal, endometrial, or ovarian cancer * Primary or recurrent disease * Locally advanced disease, defined as the following: * Stage IB2-IVA (for cervical or vaginal cancer) * Any non-extra pelvic metastatic stage (for endometrial or ovarian cancer) * Not amenable to curative surgical resection alone * Bidimensionally measurable or clinically evaluable disease * Refused or ineligible for weekly IV cisplatin chemotherapy due to renal insufficiency, prior platinum adverse sensitivity, pre-existing neuropathy, or concurrent co-morbid illness * No histologically confirmed or clinically suspicious (≥ 1 cm) para-aortic lymphadenopathy * No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age * 18 and over (80 and under for second and third dose-escalation levels) Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL Hepatic * Bilirubin ≤ 1.5 mg/dL * AST and ALT \< 2 times upper limit of normal Renal * See Disease Characteristics * Creatinine normal OR * Creatinine clearance ≥ 30 mL/min\* * No proteinuria or clinically significant impaired renal function NOTE: \*Creatine clearance testing required in patients \> 60 years of age Cardiovascular * No symptomatic New York Heart Association class III or IV congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No uncontrolled hypertension Gastrointestinal * Able to swallow oral medication * No bowel obstruction * No malabsorption illness Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to capecitabine or fluorouracil * No ongoing or active infection * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No other active invasive malignancy * Prior malignancy in remission for ≥ 6 months that is not currently being treated allowed PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Recovered from prior chemotherapy * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * Prior chemotherapy for a non-gynecologic malignancy or in the adjuvant setting allowed * No prior capecitabine Endocrine therapy * Prior adjuvant hormonal therapy allowed Radiotherapy * Recovered from prior radiotherapy * At least 4 weeks since prior radiotherapy * Prior radiotherapy for a non-gynecologic malignancy allowed * No prior low abdominal or pelvic radiotherapy Surgery * Not specified Other * At least 3 weeks since prior investigational anticancer agents and recovered * No prior anticancer treatment that contraindicates study therapy

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

Sponsors & Collaborators

Study Sites (2)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsVaginal NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CapecitabineBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVaginal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Charles Kunos, MD, PhD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 11, 2005

Study Start

April 1, 2005

Last Updated

July 8, 2011

Record last verified: 2011-07

Locations

US(2)