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Status:

WITHDRAWN

Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer

Lead Sponsor:

Case Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Cancer

Endometrial Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

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 ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of capecitabine when given in combination with pelvic external beam radiotherapy and intracavitary brachytherapy...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00118300

    Start Date

    April 1 2005

    Last Update

    July 8 2011

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

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

    Cleveland, Ohio, United States, 44106-5065

    2

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44195