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Ovarian CancerPhase 2NCT00390611

Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

A Phase 2 study testing Sorafenib, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by SCRI Development Innovations, LLC at 17 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

This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Sorafenib, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
17 sitesUnited States
Study dates
Oct 2006to Apr 2014
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

  • Histologically confirmed, stage III or IV epithelial ovarian carcinoma
  • No previous treatment with chemotherapy or radiation therapy
  • All patients must have undergone cytoreductive surgery, with the
  • following results:
  • No residual tumor nodule > 3cm
  • No residual tumor involvement of the bowel (ie. invasion into bowel
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  • wall)
  • No residual intestinal obstruction
  • Measurable or evaluable disease. Patients with elevated CA-125 levels
  • and/or evaluable disease per RECIST criteria are eligible.
  • ECOG performance status 0 or 1.
  • ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
  • Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x
  • ULN (≤ 5 x ULN for patients with liver metastases)
  • Serum creatinine _ 1.5 x ULN
  • INR < 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation
  • treatment with an agent such as warfarin or heparin may be
  • allowed to participate. For patients on warfarin, the INR may be > 1.5,
  • and should be measured prior to initiation of sorafenib and monitored at
  • least weekly until INR is stable in the desired therapeutic range.
  • Women of childbearing potential must have a negative serum pregnancy
  • test performed within 7 days prior to start of treatment.
  • Patients must be able to understand the nature of this study and give
  • written informed consent.

Who cannot join

  • Age < 18 years
  • Active cardiac disease, including: A) congestive heart failure > class II
  • NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Patients with CNS metastases. Patients with neurological symptoms
  • must undergo a CT scan/MRI of the brain to exclude brain metastasis.
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  • Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg, despite optimal medical management
  • Known HIV, chronic hepatitis B or chronic hepatitis C infections
  • Women who are pregnant or lactating. Women of childbearing potential
  • must agree to use adequate contraception from time of study entry until
  • at least 3 months after the last administration of study drug.
  • Active clinically serious infection (> grade 2)
  • Thrombotic or embolic events such as cerebral vascular accident
  • including transient ischemic attacks within the last 6 months.
  • Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of
  • starting treatment.
  • Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of
  • starting treatment
  • Serious non-healing wound, ulcer, or bone fracture
  • Evidence of history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy, or significant traumatic injury within 4 weeks
  • of starting treatment.
  • Any condition that impairs the ability to swallow whole pills
  • Patients with any type of malabsorption
  • Known or suspected allergy to any of the agents used in this treatment
  • Use of St. John's Wort or rifampin

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Medical College of Georgia Cancer Specialists

    Augusta, Georgia, 30912

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Tennessee Valley Clinical Research

    Chattanooga, Tennessee, 37411

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Center

    Newport News, Virginia, 23601

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer

This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.

Read the detailed description

All patients must be at least 4 weeks from cytoreductive surgery before starting treatment. Patients will be randomized to receive treatment with either paclitaxel/carboplatin + sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months.

  • Regimen A:

Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1

Carboplatin AUC 6 infused over 20 minutes IV, Day 1

Sorafenib 400mg PO bid

  • Regimen B:

Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1

Carboplatin AUC 6.0, 20 minute IV infusion, Day 1

Conditions
Ovarian Cancer
Keywords
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

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

Study groups in NCT00390611
Study groupRoleWhat they receive
Paclitaxel/Carboplatin/SorafenibActive comparatorPaclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Receives: Drug: Sorafenib; Drug: Paclitaxel; Drug: Carboplatin
Paclitaxel/carboplatinActive comparatorPaclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. 2-year Progression-free Survival

    The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 2 years

Secondary outcomes (3)

  1. Overall Response Rate (ORR)

    Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.

    Measured: 18 months

  2. Overall Survival (OS)

    Overall survival was measured from the date of study entry until the date of death

    Measured: 18 months

  3. Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib

    Number of patients experiencing treatment-related adverse events

    Measured: 18 months

Timeline

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

  1. First posted20 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2012
  4. Study completionApr 2014

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
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390611
Sponsor's protocol ID
SCRI GYN 19
Other IDs
SR05-918
Status last verified
Dec 2014
First submitted
19 Oct 2006
Last updated
22 Dec 2014
Data monitoring committee
No

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 Sorafenib, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by SCRI Development Innovations, LLC at 17 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 24 inclusion and 26 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 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 22 Dec 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?

2-year Progression-free Survival (time frame: 2 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 NCT00390611, 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 22 Dec 2014.

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