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Cancer of the CervixPhase 1/2NCT00510250

A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer

A Phase 1/2 study testing Sorafenib, Cisplatin and Radiation in people with Cancer of the Cervix, run by University Health Network, Toronto at 1 site in Canada.

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

This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer of the Cervix
What is being tested?
Sorafenib, Cisplatin and Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteCanada
Study dates
Jun 2007to Jul 2015
Phase
Phase 1/2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have biopsy-proven epithelial carcinoma of the cervix, T1B-3B, N0/1, M0 with visible or palpable disease and a decision to treat radically with radiotherapy and concurrent cisplatin chemotherapy (RT-CT).
  • ECOG performance status 0, 1 or 2 (Karnofsky>=60%)
  • Life expectancy of greater than 12 weeks.
  • Patients must have normal organ and marrow function as defined below:
  • Leukocytes >3,000/mcL
  • Absolute neutrophil count >1,500/mcL
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  • Platelets >100,000/mcL
  • Hemoglobin > 9 g/dL
  • Total bilirubin Within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal
  • Creatinine Within normal institutional limits, or
  • Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above normal
  • No prior treatment for cervix cancer.
  • The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. Although radical RT-CT for cervix cancer is not compatible with survival of a developing fetus, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • No active malignancy at another site.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients may not be receiving any other investigational agents concurrently or within 4 weeks. Patients who have previous exposure to a raf-kinase inhibitor are excluded
  • Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher) are ineligible.
  • Patients with any condition that impairs their ability to swallow sorafenib tablets are excluded (e.g. gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease).
  • Bleeding disorders. Patients cannot be receiving therapeutic anticoagulation. Prophylactic anticoagulation (ie. low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT, INR, or PTT are met.
  • Patients with known brain metastases should be excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. These patients would not be eligible for radical RT-CT for cervix cancer, but instead would be treated for palliation.
  • Patients with intercurrent cardiac dysfunction including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia are excluded as are those with a history of ischemic heart disease including myocardial infarction.
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because sorafenib has the potential for teratogenic or abortifacient effects as shown by the gross fetal malformations and effects on embryo-fetal survival seen in reproductive toxicity studies in the rat. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sorafenib, breastfeeding should be discontinued if the mother is treated with sorafenib.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sorafenib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • A decision to treat with extended-field pelvic and para-aortic radiotherapy, specifically cases where the para-aortic field will extend cranial to the L3-4 vertebral inter-space.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer.

Read the detailed description

During the phase I component of the study, low risk patients (tumor size ≤5 cm and radiographically node negative) will receive sorafenib alone in escalating doses for at least 1 week prior to the start of conventional treatment with radiotherapy and chemotherapy (RT-CT). High risk patients (tumor > 5 cm or node positive) will receive sorafenib alone in escalating dose for at least 1 week prior to the start of RT-CT, as well as concurrently with RT-CT. Cohorts of 3 patients per dose level are planned. If 1/3 patients encounters a dose-limiting toxicity (DLT), then that cohort will be expanded to 6 patients. If >2/3 of patients encounter a DLT, then that dose level will be declared as the maximum tolerated dose (MTD). An additional 3 patients will be entered into the dose level one below the MTD. The recommended phase II dose (RPTD) is defined as the dose level with < 1/6 patients with DLT.

For the phase II component, all patients will receive sorafenib at the RPTD for at least 1 week prior to, and concurrent with, RT-CT.

Keywords
Cervix Cancer, Cervical Cancer, Sorafenib, Cisplatin, Radiation, Radiotherapy, Phase I, Phase II, Carcinoma, Cancer, Cervix
Medical subject headings
Uterine Cervical Neoplasms, Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    200mg PO BID x 7 days prior to Radiation and Cisplatin for Low-Risk Patients or 200mg PO BID x 7 days prior to, and 35 days during Radiation and Cisplatin for High-Risk Patients

  • CisplatinDrug

    40mg/m2 administered weekly via IV, with Radiation

  • RadiationProcedure or surgery

    Administered for 30-40 days.Combination of external beam radiotherapy followed by intra-cavitary brachytherapy.

Study groups in NCT00510250
Study groupRoleWhat they receive
Cisplatin and Radiation in Combination with SorafenibExperimentalNot described
Receives: Drug: Sorafenib; Drug: Cisplatin; Procedure: Radiation

What is being measured

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

  1. Determine the biologic activity of sorafenib in cervix cancer.

    Measured: Not Determined

Secondary outcomes (1)

  1. Determine the acute and late toxicity, and effect of sorafenib in combination with radiation and chemotherapy on the disease-free survival of patients with high-risk cervix cancer.

    Measured: Not Determined

Timeline

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

  1. First posted1 Aug 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionSep 2010
  4. Study completionJul 2015

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00510250
Sponsor's protocol ID
DDPDRO-002
Other IDs
Bayer Protocol# 12138
Status last verified
Jul 2015
First submitted
31 Jul 2007
Last updated
27 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sorafenib, Cisplatin and Radiation in people with Cancer of the Cervix, run by University Health Network, Toronto at 1 site in Canada.

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 16 inclusion and 10 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 combined 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.

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.

What does the primary outcome measure?

Determine the biologic activity of sorafenib in cervix cancer. (time frame: Not Determined). 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 NCT00510250.

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 Jul 2015.

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