AzTrials
AzTrials

Cervical CancerPhase 2NCT00548418

Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer

A Phase 2 study testing Topotecan, Cisplatin and Bevacizumab in people with Cervical Cancer, run by Washington University School of Medicine at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Topotecan, Cisplatin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesUnited States
Study dates
Feb 2007to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Recurrent or persistent squamous, adenosquamous or adenocarcinoma of the uterine cervix not amenable to curative treatment with surgery and/or radiotherapy
  • No prior therapy (radiation, chemotherapy, hormonal therapy or immunotherapy) for recurrence or persistence. May have received platinum in combination with radiation as part of up-front treatment or adjuvant treatment
  • Must have measurable disease as defined by RECIST criteria
  • Must have at least one "target lesion" to assess response
  • Performance status of 0 or 1
  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Show all 15Show fewer
  • At least 4 weeks must have elapsed since prior treatment
  • Age >= 18 years
  • Patients of childbearing potential must have a negative pregnancy test, use effective means of contraception
  • Signed informed consent
  • Bone marrow function: ANC >= 1500/ul; platelets >= 100,000 /ul
  • Renal function: creatinine <= 1,5 X ULN (if > 1.5 creatinine clearance must be > 60 ml/min)
  • Hepatic function: bilirubin <= 1.5 X ULN, AST and alkaline phosphatase <= 2.5 X ULN
  • Neurologic function: neuropathy < CTC grade 1
  • Coagulation: PT INR <= 1.5

Who cannot join

  • Evidence of sepsis or severe infection
  • Prior therapy for recurrence
  • Patients with serious, non-healing wound, ulcer or bone fracture
  • Patients with history or evidence of nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, CVA, stroke, TIA or subarachnoid hemorrhage within 6 months of 1st date of treatment on study
  • Patients with history of other invasive malignancy (treatment within last 5 years) other than non-melanoma skin cancer
  • Patient with clinically significant cardiovascular disease defined as:
Show all 24Show fewer
  • Inadequately controlled hypertension (systolic > 150 and/or diastolic > 100 on antihypertensive medications); prior history of hypertensive crisis or hypertensive encephalopathy
  • Unstable angina within 6 months of enrollment
  • NYHA Grade II or greater congestive heart failure
  • Serious cardiac arrythmia requiring medication
  • Grade 2 or greater peripheral vascular disease; claudication within 6 months
  • History of myocardial infarction within 6 months
  • Previously diagnosed coagulopathy, disseminated intravascular coagulopathy, immune thrombocytopenia purpura, thrombotic thrombocytopenia purpura or tumor involving major vessels
  • Significant vascular disease: aortic aneurysm, aortic dissection
  • Active thromboembolic disease: pulmonary embolism, deep venous thrombosis
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study; anticipation of need for major surgical procedure during course of the study
  • Minor surgical procedure other than central venous access placement, within 7 days prior to day 1 of study
  • Patients with proteinuria - patients with urine protein of 1+ on dipstick or >=30 mg/dl at baseline should undergo UPCR; patients with UPCR of >=1.0 should be excluded
  • Patients who are pregnant or lactating
  • No prior investigational agent within 30 days or planned participation in an experimental drug study
  • Patients whose circumstances do not permit completion of study or required follow-up
  • Prior therapy with bevacizumab or topotecan. Prior platinum therapy allowed as part of initial treatment
  • History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 months prior to study enrollment.
  • Known hypersensitivity to any component of bevacizumab

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Ohio State University College of Medicine

    Columbus, Ohio

  • Duke Cancer Institute

    Durham, North Carolina

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer

The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer

Read the detailed description

Cervical cancer remains a major cause of morbidity and mortality in women. Chemoradiation has led to improvements in survival, but the prognosis for patients with recurrent, metastatic cervical cancer remains poor. There is the need for more effective treatments for the management of recurrent/persistent cervical cancer. Angiogenesis appears to play an important role in cervical cancer development and progression, therefore VEGF inhibition appears to be a rationale therapeutic strategy for cervical cancer. There is increasing evidence that combining an anti-angiogenic agent with either cytotoxic chemotherapy or radiation enhances anti-tumor activity. This study combines the current most active chemotheraputic regimen for cervical cancer (cisplatin + topotecan) with an anti-angiogenic agent.

Conditions
Cervical Cancer
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.

Study groups in NCT00548418
Study groupRoleWhat they receive
IExperimentalCisplatin 50 mg/m2 IV day 1 of a 21 day cycle Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle Bevacizumab 15 mg/kg day 1 of a 21 day cycle
Receives: Drug: Topotecan; Drug: Cisplatin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-tumor Activity as Measured by Surviving Progression-free

    Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.

    Measured: Progression-free survival at 6 months

Secondary outcomes (4)

  1. Overall Survival

    Defined as time from study entry until death from any cause or date of last contaqct.

    Measured: Until death (follow-up ranged from 1.7 months to 33.4 months)

  2. Frequency of Response as Measured by RECIST Criteria (Imaging)

    RECIST criteria:

    Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

    Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions

    Stable disease is any condition not meeting the above criteria

    Measured: Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)

  3. Correlate Patterns of Gene Expression as Assessed by Microarrays

    Measured: Correlative studies when specimens available

  4. Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies

    Measured: When specimens available

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionDec 2012
  4. Study completionDec 2012

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00548418
Sponsor's protocol ID
06-1098 / 201110266
Other IDs
GSK 107278
Status last verified
Jul 2014
First submitted
23 Oct 2007
Last updated
1 Aug 2014
Data monitoring committee
Yes

Publications

  • Zighelboim I, Wright JD, Gao F, Case AS, Massad LS, Mutch DG, Powell MA, Thaker PH, Eisenhauer EL, Cohn DE, Valea FA, Alvarez Secord A, Lippmann LT, Dehdashti F, Rader JS. Multicenter phase II trial of topotecan, cisplatin and bevacizumab for recurrent or persistent cervical cancer. Gynecol Oncol. 2013 Jul;130(1):64-8. doi: 10.1016/j.ygyno.2013.04.009. Epub 2013 Apr 13.

    PubMed 23591400

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan, Cisplatin and Bevacizumab in people with Cervical Cancer, run by Washington University School of Medicine at 3 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?

The sponsor lists 15 inclusion and 24 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anti-tumor Activity as Measured by Surviving Progression-free (time frame: Progression-free survival at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00548418, 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 1 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in