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Recurrent Ovarian Epithelial CancerPhase 2NCT00096395

Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer

A Phase 2 study testing gemcitabine hydrochloride, sorafenib tosylate and laboratory biomarker analysis in people with Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) 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 phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, sorafenib tosylate and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteCanada
Study dates
Sep 2004to Feb 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed epithelial ovarian cancer or primary peritoneal cancer that has recurred or is refractory to initial therapy; patients must have received platinum-based chemotherapy before entry into this protocol
  • Patients who have recurred and are platinum-sensitive (treatment free interval greater than 12 months) must have been re-treated with platinum-based chemotherapy prior to entry into this protocol
  • Patients may have received no more than three prior chemotherapy regimens (e.g. initial chemotherapy and two regimens for subsequent relapses)
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; if measurable disease is in a radiated site, there must be evidence of disease progression in that lesion post radiation
  • Life expectancy of greater than 12 weeks
  • ECOG performance status =<1 (Karnofsky >= 70%)
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  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • 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 m^2 for patients with creatinine levels above institutional normal
  • The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men 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
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients who are on warfarin anticoagulation are allowed to participate as long as they fit the following 4 criteria:
  • They are therapeutic on a stable warfarin dose
  • Their INR target range is no greater than 3
  • They are monitored with weekly INR, PT and PTT testing
  • They have no active bleeding or pathological condition that carries high risk of bleeding
  • Pregnant women are excluded from this study because BAY 43-9006 is a kinase inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 43-9006, breastfeeding should be discontinued if the mother is treated with BAY 43-9006

Who cannot join

  • Patients who have had chemotherapy, radiotherapy, hormonal or biologic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients with borderline tumours or tumours of low malignant potential
  • Patients with current bowel obstruction
  • Patients with previous radiotherapy to > 30% of bone marrow irradiated in target volume and/or radiotherapy within 4 weeks of study treatment; palliative radiation is allowed within 4 weeks of treatment, after discussion with the Principal Investigator
  • 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 known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 or other agents used in the study
  • Patients may not have had prior gemcitabine chemotherapy
  • No concurrent use of itraconazole, ketoconazole, ritanovir, or grapefruit juice
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital Phase 2 Consortium

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 2 Study of BAY 43-9006 in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer

This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES I. Objective tumour response rate (complete plus partial response as defined by the RECIST criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer.

SECONDARY OBJECTIVES:

  1. Median survival time. II. 6-month survival rate. III. Objective tumour stable disease rate. IV. Response duration. V. Toxicity. VI. Time to disease progression.

OUTLINE: This is a multicenter study.

Course 1 (56 days): Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

Course 2 and all subsequent courses (28 days): Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients with a complete or partial response receive at least 2 additional courses beyond documented response. Patients with stable or responding disease who have received at least 6 courses may discontinue gemcitabine and continue sorafenib alone until disease progression.

Being tested
gemcitabine hydrochloride, sorafenib tosylate, laboratory biomarker analysis
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00096395
Study groupRoleWhat they receive
Treatment (sorafenib tosylate, gemcitabine hydrochloride)ExperimentalCourse 1 (56 days): Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Course 2 and all subsequent courses (28 days): Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: gemcitabine hydrochloride; Drug: sorafenib tosylate; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective tumor response rate (complete plus partial response as defined by the RECIST criteria)

    Measured: Up to 7 years

Secondary outcomes (6)

  1. Median survival time

    Estimated using the Kaplan Meier method.

    Measured: Up to 7 years

  2. Survival rate

    Estimated using the Kaplan Meier method.

    Measured: 6 months

  3. Objective tumor stable disease rate, graded according to RECIST criteria

    Ninety-five percent confidence intervals will be provided.

    Measured: Up to 7 years

  4. Response duration

    Ninety-five percent confidence intervals will be provided.

    Measured: Up to 7 years

  5. Toxicity, graded using the CTCAE

    Measured: Up to 7 years

  6. Time to disease

    Measured: Up to 7 years

Timeline

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

  1. First posted9 Nov 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionFeb 2007

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096395
Sponsor's protocol ID
NCI-2012-03057
Other IDs
PHL-025, 6565, N01CM62203
Status last verified
May 2013
First submitted
9 Nov 2004
Last updated
13 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, sorafenib tosylate and laboratory biomarker analysis in people with Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) 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 20 inclusion and 11 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 13 Jun 2013. 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 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.

What does the primary outcome measure?

Objective tumor response rate (complete plus partial response as defined by the RECIST criteria) (time frame: Up to 7 years). 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 NCT00096395.

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 13 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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