Cervical CancerPhase 2NCT00016926
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
A Phase 2 study testing capecitabine in people with Cervical Cancer, run by Gynecologic Oncology Group at 10 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- capecitabine
- How many people
- Not given
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2001to Jul 2007
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix
- Documented disease progression after local therapy and considered incurable
- At least 1 target lesion measurable in at least 1 dimension
- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- Target lesion cannot be in a previously irradiated field
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No neuropathy (sensory and motor) greater than grade I
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
- At least 3 weeks since prior chemotherapy for the malignant tumor and recovered
- No prior cytotoxic therapy (except when used as a radiosensitizer)
- No prior chemotherapy for other malignancy
Endocrine therapy:
- At least 1 week since prior hormonal therapy for the malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
- No prior radiotherapy for other malignancy
Surgery:
- Recovered from prior surgery
Other:
- At least 3 weeks since any other prior therapy for the malignant tumor
- No prior anticancer therapy that contraindicates study therapy
- No concurrent amifostine or other protective reagents
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
University of Texas Medical Branch
Galveston, Texas, 77555-0587
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
Brookview Research, Inc.
Nashville, Tennessee, 37203
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065
About this study
Official title: A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.
Read the detailed description
OBJECTIVES:
- Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
- Determine the toxicity profile of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.
- Conditions
- Cervical Cancer
- Being tested
- capecitabine
- Keywords
- stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Agustin Garcia, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016926
- Sponsor's protocol ID
- CDR0000068633
- Other IDs
- GOG-0076CC
- Status last verified
- May 2004
- First submitted
- 6 Jun 2001
- Last updated
- 27 May 2013
- Results posted
- No
Publications
Garcia AA, Blessing JA, Darcy KM, Lenz HJ, Zhang W, Hannigan E, Moore DH. Phase II clinical trial of capecitabine in the treatment of advanced, persistent or recurrent squamous cell carcinoma of the cervix with translational research: a gynecologic oncology group study. Gynecol Oncol. 2007 Mar;104(3):572-9. doi: 10.1016/j.ygyno.2006.09.002. Epub 2006 Oct 17.
PubMed 17049588
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
- ClinicalTrials.gov ID
- NCT00016926
- Acronym / sponsor ID
- CDR0000068633
- Conditions
- Cervical Cancer
- Keywords
- stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- Primary completion
- Jul 2007 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.
Detailed description
OBJECTIVES:
- Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
- Determine the toxicity profile of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| capecitabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Results publication: PubMed 17049588Garcia AA, Blessing JA, Darcy KM, Lenz HJ, Zhang W, Hannigan E, Moore DH. Phase II clinical trial of capecitabine in the treatment of advanced, persistent or recurrent squamous cell carcinoma of the cervix with translational research: a gynecologic oncology group study. Gynecol Oncol. 2007 Mar;104(3):572-9. doi: 10.1016/j.ygyno.2006.09.002. Epub 2006 Oct 17.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
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.
Agustin Garcia, MD study chair
University of Southern California
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine in people with Cervical Cancer, run by Gynecologic Oncology Group at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00016926, which also lists 1 linked publication.
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 27 May 2013.