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Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies

Phase 1
18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vaginal Cancer

Thank you

Trial Information

Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies



- Determine the maximum tolerated dose and dose-limiting toxicity of capecitabine when
given in combination with pelvic external beam radiotherapy and intracavitary
brachytherapy in patients with primary or recurrent locally advanced cervical cancer or
other pelvic malignancy.


- Determine the clinical anti-tumor response in patients treated with this regimen.

- Determine adverse clinical sequelae in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of capecitabine.

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

NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the
majority of external beam radiotherapy has been administered, HDR brachytherapy may be
administered in 2 applications per week (separated by at least 72 hours) in order to
complete all treatment by week 8.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the

After completion of study treatment, patients are followed at 1 month, every 3 months for 1
year, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: Approximately 4-24 patients will be accrued for this study within 2-12

Inclusion Criteria


- 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

- No brain metastases or primary brain tumors



- 18 and over (80 and under for second and third dose-escalation levels)

Performance status

- GOG 0-2

Life expectancy

- Not specified


- 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


- Bilirubin ≤ 1.5 mg/dL

- AST and ALT < 2 times upper limit of normal


- 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


- No symptomatic New York Heart Association class III or IV congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No uncontrolled hypertension


- Able to swallow oral medication

- No bowel obstruction

- No malabsorption illness


- 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


Biologic therapy

- Not specified


- 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

- No prior capecitabine

Endocrine therapy

- Prior adjuvant hormonal therapy allowed


- 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


- Not specified


- At least 3 weeks since prior investigational anticancer agents and recovered

- No prior anticancer treatment that contraindicates study therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:


Safety Issue:


Principal Investigator

Charles Kunos, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Federal Government

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Vaginal Cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • recurrent cervical cancer
  • stage III endometrial carcinoma
  • recurrent endometrial carcinoma
  • stage III ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • stage III vaginal cancer
  • stage IVA vaginal cancer
  • recurrent vaginal cancer
  • ovarian sarcoma
  • ovarian stromal cancer
  • stage IV endometrial carcinoma
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage II vaginal cancer
  • stage I vaginal cancer
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Adenoma



Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195