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Primary Peritoneal CarcinomaPhase 2NCT00093626

Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

A Phase 2 study testing Laboratory Biomarker Analysis and Sorafenib Tosylate in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 1 site 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 stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Laboratory Biomarker Analysis and Sorafenib Tosylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
Oct 2004to Jan 2011
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Persistent or recurrent disease
  • Measurable or evaluable disease
  • Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
  • Evaluable disease is defined as at least 1 of the following:
  • CA 125 ≥ 2 times upper limit of normal (ULN)
Show all 67Show fewer
  • Ascites and/or pleural effusion attributed to tumor
  • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions
  • Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound
  • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Platinum-resistant according to 1 of the following criteria:
  • Treatment-free interval of < 12 months after platinum therapy
  • Disease progression during platinum-based therapy
  • Persistent disease after a platinum-based regimen
  • Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
  • No brain metastases
  • Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
  • Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding diathesis
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • Able to take oral medication
  • No bowel obstruction or persistent vomiting
  • No requirement for parenteral feedings
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No sensory or motor neuropathy > grade 1
  • No active or ongoing infection requiring antibiotics
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No serious chronic skin conditions (i.e., psoriasis or dermatitis) that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • At least 3 weeks since prior immunologic agents for the malignancy
  • More than 4 weeks since prior mouse antibodies (for patients with evaluable disease only)
  • No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF])
  • No concurrent prophylactic thrombopoietic agents except in the case of recurrent grade 4 thrombocytopenia
  • No other concurrent biological agents for the primary tumor
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior non-cytotoxic chemotherapy for persistent or recurrent disease
  • No concurrent chemotherapy for the primary tumor
  • At least 1 week since prior hormonal therapy for the malignancy
  • No concurrent hormonal therapy for the primary tumor
  • Concurrent hormone replacement therapy allowed
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No concurrent radiotherapy
  • More than 4 weeks since prior surgery involving the peritoneum or pleura (for patients with evaluable disease only)
  • Recovered from prior surgery
  • At least 3 weeks since other prior therapy for the malignancy
  • No more than 1 additional prior cytotoxic regimen for persistent or recurrent disease
  • No prior sorafenib
  • No prior anticancer treatment that would preclude study participation
  • No concurrent therapeutic oral anticoagulation therapy (i.e., warfarin)
  • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for central venous access devices allowed provided INR is < 1.5
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation of BAY 43-9006 (Sorafenib, Nexavar®, NCI-Supplied Agent, NSC #724772) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.

II. Determine 6-month progression-free survival of patients treated with this drug.

III. Determine the toxicity of this drug, in terms of frequency and severity of adverse events encountered, in these patients.

SECONDARY OBJECTIVES:

  1. Determine the clinical response rate (partial and complete response) in patients treated with this drug.

II. Determine the duration of progression-free and overall survival of patients treated with this drug.

III. Correlate prognostic variables (platinum sensitivity, performance status, and histology [clear cell and mucinous type]) with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

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 are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 6-13 months.

Being tested
Laboratory Biomarker Analysis, Sorafenib Tosylate
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Sorafenib TosylateDrug

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

    Given orally

Study groups in NCT00093626
Study groupRoleWhat they receive
Treatment (sorafenib tosylate)ExperimentalPatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Drug: Sorafenib Tosylate

What is being measured

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

  1. Frequency and severity of adverse events as assessed by CTCAE v3.0

    Measured: Up to 5 years

  2. Progression-free survival

    Will be evaluated using proportional hazards modeling and Fisher's exact test.

    Measured: 6 months

Secondary outcomes (4)

  1. Duration of overall survival

    Will be evaluated using proportional hazards modeling and Fisher's exact test.

    Measured: Up to 5 years

  2. Duration of progression-free survival

    Will be evaluated using proportional hazards modeling and Fisher's exact test.

    Measured: Up to 5 years

  3. Frequency of clinical response (complete and partial response) defined by RECIST criteria

    Measured: Up to 5 years

  4. Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type])

    Measured: Up to 5 years

Timeline

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

  1. First posted8 Oct 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionSep 2007
  4. Study completionJan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093626
Sponsor's protocol ID
NCI-2012-02624
Other IDs
NCI-2012-02624, CDR0000389246, GOG-0170F, GOG-0170F, U10CA027469
Status last verified
Jul 2019
First submitted
6 Oct 2004
Last updated
23 Jul 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Sorafenib Tosylate in people with Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 1 site 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 67 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 23 Jul 2019. 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 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?

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?

Frequency and severity of adverse events as assessed by CTCAE v3.0 (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 NCT00093626.

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 23 Jul 2019.

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