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Recurrent Fallopian Tube CarcinomaPhase 2NCT00096200

Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

A Phase 2 study testing Carboplatin, Paclitaxel and Sorafenib Tosylate in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 5 sites in United States.

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

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 paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Paclitaxel and Sorafenib Tosylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
5 sitesUnited States
Study dates
Aug 2004to Aug 2011
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

  • Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Recurrent disease
  • Must have received a prior platinum-based regimen
  • Platinum-sensitive (treatment-free interval > 6 months)
  • No more than 2 prior chemotherapy regimens
  • Measurable disease
Show all 55Show fewer
  • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • Not in a prior irradiation field
  • No known brain metastases
  • Performance status:
  • ECOG 0-2 OR
  • Karnofsky 80-100%
  • Life expectancy:
  • More than 12 weeks
  • Hematopoietic:
  • Absolute neutrophil count >= 1,500/mm3
  • Platelet count >= 100,000/mm3
  • Hemoglobin >= 9 g/dL
  • No bleeding diathesis
  • Hepatic:
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT =< 2 times ULN
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
  • Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study
  • No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:
  • Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully
  • Renal:
  • Creatinine < 2 mg/dL
  • Cardiovascular:
  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months
  • No symptomatic congestive heart failure
  • No uncontrolled hypertension
  • No cardiac arrhythmia
  • No unstable angina pectoris;
  • No myocardial infarction within the past 6 months
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate intestinal function
  • No concurrent requirements for IV hydration or nutritional support
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • No other invasive malignancy with the past 5 years except nonmelanoma skin cancer
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • More than 3 weeks since prior hormonal therapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior sorafenib
  • No prior anticancer therapy that contraindicates study therapy
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic anticoagulation therapy
  • Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices
  • No other concurrent anticancer therapies
  • No other concurrent investigational agents
  • Not pregnant or nursing

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Moffitt Cancer Center at Tampa General Hospital

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube 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 paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).

Read the detailed description

PRIMARY OBJECTIVES :

  1. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.

ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days 1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II.

ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Being tested
Carboplatin, Paclitaxel, Sorafenib Tosylate
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Sorafenib TosylateDrug

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

    Given orally

Study groups in NCT00096200
Study groupRoleWhat they receive
Arm I (closed to accrual 10/10/2008)ExperimentalPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
Receives: Drug: Sorafenib Tosylate
Arm IIExperimentalPatients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Sorafenib Tosylate

What is being measured

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

  1. Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.

    Measured: after 6 weeks (2 cycles)

Secondary outcomes (2)

  1. Evaluate the Progression-free Survival Rate

    Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.

    Measured: up to 85 months of follow-up

  2. Overall Survival

    Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.

    Measured: up to 85 months of follow-up

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 startAug 2004
  3. Primary completion21 Apr 2011
  4. Study completionAug 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096200
Sponsor's protocol ID
NCI-2009-00067
Other IDs
NCI-2009-00067, CASE 2804, CDR0000390331, CASE 2804, 6557, N01CM62208, P30CA043703, U01CA062502
Status last verified
Jan 2022
First submitted
9 Nov 2004
Last updated
8 Feb 2022

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Sorafenib Tosylate in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 5 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 55 inclusion and 0 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 13 Dec 2012). 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?

Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (time frame: after 6 weeks (2 cycles)). 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 NCT00096200, 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 8 Feb 2022.

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