Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Endometrial Cancer Ovarian Cancer Vaginal Cancer |
Drug: capecitabine Radiation: brachytherapy Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies |
- Maximum tolerated dose [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- Disease response measured prior to brachytherapy and at 1 month after completion of study treatment [ Time Frame: 1 month after completion of study treatment ] [ Designated as safety issue: No ]
- Toxicity as measured by CTC v 3.0 weekly [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | April 2005 |
-
Drug: capecitabine
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Charles Kunos, MD, PhD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Charles Kunos, MD, PhD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00118300 History of Changes |
| Other Study ID Numbers: | CASE9804, P30CA043703, CASE-9804, CWRU-010514 |
| Study First Received: | July 8, 2005 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Vaginal Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Endocrine System Diseases Gonadal Disorders Vaginal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Capecitabine Fluorouracil Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013