Cervical CancerPhase 2NCT00026260
SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase 2 study testing semaxanib in people with Cervical Cancer, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have 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?
- semaxanib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2003
- 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 cervical squamous cell carcinoma
- Persistent or recurrent disease with documented progression
- No nonsquamous cell cervical malignancies, including adenosquamous carcinoma
- At least 1 measurable lesion
- 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
- Failed prior local therapeutic measures
- Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population)
- Tumor must be accessible for biopsy using direct- or guided-needle technique
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least lower limit of normal
- Absolute neutrophil count at least 1,500/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 no greater than 1.5 times ULN OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No uncompensated coronary artery disease on electrocardiogram or physical examination
- No myocardial infarction within the past 6 months
- No severe/unstable angina within the past 6 months
- No severe peripheral vascular disease
- No deep vein or arterial thrombosis within the past 3 months
Pulmonary:
- No pulmonary embolism within the past 3 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must have central venous access
- No uncontrolled diabetes mellitus
- No prior allergic reaction to paclitaxel
- No active infection requiring antibiotics
- No peripheral neuropathy greater than grade 1
- No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin prophylaxis
- No claustrophobia that would preclude MRI studies
- No ferromagnetic implants or pacers
- No other invasive malignancy within the past 5 years except non-melanoma skin cancer
- No other concurrent circumstances that would preclude study completion
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Biologic therapy:
- No prior antiangiogenesis agents, including SU5416
- At least 3 weeks since prior biologic or immunologic agents directed at malignancy
Chemotherapy:
- No more than 1 prior chemotherapy regimen, including single or combination cytotoxic drug therapy (radiosensitizers do not count as prior regimen)
- At least 3 weeks since prior chemotherapy directed at malignancy and recovered
Endocrine therapy:
- At least 1 week since prior hormonal therapy directed at malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- At least 3 weeks since prior radiotherapy directed at malignancy and recovered
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior surgery for malignancy and recovered
Other:
- No prior cancer therapy that would preclude study
About this study
Official title: A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly 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: Approximately 19-51 patients will be accrued for this study within 8-23 months.
- Conditions
- Cervical Cancer
- Being tested
- semaxanib
- Keywords
- recurrent 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.
semaxanibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2003 (estimated)
- Study completionOct 2003
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.
- 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
- Robert A. Burger, MD, Study chair, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026260
- Sponsor's protocol ID
- CDR0000069013
- Other IDs
- GOG-0227B
- Status last verified
- Jun 2007
- First submitted
- 9 Nov 2001
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT00026260
- Acronym / sponsor ID
- CDR0000069013
- Conditions
- Cervical Cancer
- Keywords
- recurrent 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 completion
- Oct 2003 (actual)
- First posted
- 21 Oct 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: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly 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: Approximately 19-51 patients will be accrued for this study within 8-23 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 |
|---|---|---|
| semaxanib | 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 24 Jun 2013.
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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.
Robert A. Burger, MD study chair
Chao Family Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semaxanib in people with Cervical Cancer, run by Gynecologic Oncology Group.
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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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 24 Jun 2013.