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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
N/A
Not Enrolling
Female
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


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 in patients with primary or recurrent locally advanced cervical cancer or
other pelvic malignancy.

Secondary

- 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
toxicity.

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
MTD.

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
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

weekly

Safety Issue:

Yes

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

Authority:

United States: Federal Government

Study ID:

CASE9804

NCT ID:

NCT00118300

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

Name

Location

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