Cervical CancerPhase 1NCT00118300
Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer
A Phase 1 study testing capecitabine, brachytherapy and radiation therapy in people with Cervical Cancer and Endometrial Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- What is being tested?
- capecitabine, brachytherapy and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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
About this study
Official title: Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
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.
Read the 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 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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vaginal Cancer
- Being tested
- capecitabine, brachytherapy, radiation therapy
- Keywords
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: weekly
Disease response measured prior to brachytherapy and at 1 month after completion of study treatment
Measured: 1 month after completion of study treatment
Toxicity as measured by CTC v 3.0 weekly
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startApr 2005
Why it stopped: Competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Charles Kunos, MD, PhD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118300
- Sponsor's protocol ID
- CASE9804
- Other IDs
- P30CA043703, CASE-9804, CWRU-010514
- Status last verified
- Jul 2011
- First submitted
- 8 Jul 2005
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
- ClinicalTrials.gov ID
- NCT00118300
- Acronym / sponsor ID
- CASE9804
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vaginal Cancer
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Competing studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2005
- First posted
- 11 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabinePatients 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. | Drug | – |
| brachytherapy1 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 | – |
| radiation therapyPatients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5. | Radiation | – |
Primary outcome
Maximum tolerated dose
Time frame: weekly
Disease response measured prior to brachytherapy and at 1 month after completion of study treatment
Time frame: 1 month after completion of study treatment
Toxicity as measured by CTC v 3.0 weekly
Time frame: weekly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Kunos, MD, PhD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine, brachytherapy and radiation therapy in people with Cervical Cancer and Endometrial Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: weekly). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.