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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
What is being tested?
capecitabine, brachytherapy and radiation therapy
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

Other trials in United States

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.

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.

  1. Maximum tolerated dose

    Measured: weekly

  2. Disease response measured prior to brachytherapy and at 1 month after completion of study treatment

    Measured: 1 month after completion of study treatment

  3. 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.

  1. First posted11 Jul 2005 (estimated)
  2. Study startApr 2005

Why it stopped: Competing studies

Resources

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)
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

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.

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