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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

  1. First posted21 Oct 2003 (estimated)
  2. Study completionOct 2003

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 2
Primary purpose
Treatment
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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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