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Cervical Squamous Cell CarcinomaPhase 2NCT00499031

Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase 2 study testing Cetuximab in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Carcinoma, run by Gynecologic Oncology Group at 22 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 phase II trial is studying cetuximab to see how well it works in treating patients with persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
22 sitesUnited States
Study dates
Jun 2007to Jan 2012
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

  • Patients must have persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy)
  • Histologic documentation of the original primary tumor is required via the pathology report
  • All patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
  • Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, and MRI, OR ≥ 10 mm when measured by spiral CT scan
  • Patients must have at least one target lesion to be used to assess response on this protocol
  • Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
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  • Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
  • Chemotherapy administered in conjunction with primary radiation as a radiosensitizer is not counted as a systemic chemotherapy regimen
  • Patients must not be eligible for a higher priority GOG protocol, if one exists
  • In general, this would refer to any active GOG phase III protocol for the same patient population
  • Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2 or patients who have received two prior regimens must have a GOG performance status of 0 or 1
  • Patients should be free of active infection requiring antibiotics
  • Platelet count ≥ 100,000/μl
  • ANC ≥ 1,500/μl
  • Creatinine ≤ 1.5 x institutional upper limit normal (ULN)
  • Bilirubin ≤ 1.5 x ULN
  • SGOT and alkaline phosphatase ≤ 2.5 x ULN
  • Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1
  • Calcium < 11.0 mg/dL
  • Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration (continuation of hormone replacement therapy is permitted)
  • Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent cervical disease according to the following definition:
  • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
  • Patients must not have received any non-cytotoxic therapy for management of recurrent or persistent cervical disease
  • Patients must not be receiving any other investigational agent

Who cannot join

  • Patients with craniospinal metastases
  • Patients with a history of other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last five years
  • Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias) within 6 months of registration
  • Patients who have an uncontrolled seizure disorder or active neurological disease
  • Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range
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  • Pregnant or nursing women or women of childbearing potential unless using effective contraception as determined by the investigator
  • Known hemorrhagic diathesis or active bleeding disorder
  • Patients who have received prior therapy with cetuximab or any other anti-epidermal growth factor receptor antibody
  • Patients who have received any prior therapy with a tyrosine kinase inhibitor that targets the EGFR pathway
  • Patients who have received prior chimerized or murine monoclonal antibody therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervical cancer within the last five years are excluded
  • Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of cervical cancer within the last five years are excluded
  • Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration and that the patient remains free of recurrent or metastatic disease
  • Patients who have undergone major surgery, excluding diagnostic biopsy, within 30 days (to allow for full recovery) prior to registration

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44307

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

Other trials in United States

About this study

Official title: A Phase II Evaluation of Cetuximab (Erbitux®, C225, NSC# 714692) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

This phase II trial is studying cetuximab to see how well it works in treating patients with persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the activity of cetuximab for patients with persistent or recurrent carcinoma of the cervix.

II. To determine the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response.

SECONDARY OBJECTIVES:

  1. To characterize the distribution of progression-free survival and overall survival.

II. To determine the effect of cetuximab on the duration of objective response in persistent or recurrent carcinoma of the cervix.

III. To determine the nature and degree of toxicity of cetuximab as assessed by CTCAE v3.0 in this cohort of patients.

OUTLINE:

Patients receive cetuximab IV over 120 minutes on day 1. Courses repeat once weekly in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed (with physical exams and histories) every three months for the first two years and then every six months for the next three years.

Being tested
Cetuximab
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • CetuximabBiological

    Also called Chimeric MoAb C225, Erbitux, IMC-C225

    Given IV

Study groups in NCT00499031
Study groupRoleWhat they receive
Treatment (cetuximab)ExperimentalPatients receive cetuximab IV over 120 minutes on day 1.
Receives: Biological: Cetuximab

What is being measured

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

  1. Progression-free Survival Greater Than 6 Months

    Measured: At 6 months

  2. Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Stable Disease is any condition not meeting the above criteria.

    Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

    Measured: every other cycle for the first 6 months; then every 3 months x 2; then every 6 months

Secondary outcomes (4)

  1. Duration of Progression-free Survival

    Measured: From study entry until disease progression, death or date of last contact, up to 5 years

  2. Duration of Objective Response Rate

    Measured: Up to 5 years

  3. Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

    Measured: Up to 5 years

  4. Duration of Overall Survival

    Measured: From study entry to death or the date of last contact, 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 posted11 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionJan 2012

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00499031
Sponsor's protocol ID
GOG-0227E
Other IDs
NCI-2009-00596, BMS-CA225-275, CDR0000554455, GOG-0227E, GOG-0227E, U10CA027469
Status last verified
Dec 2014
First submitted
10 Jul 2007
Last updated
13 Jan 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Carcinoma, run by Gynecologic Oncology Group at 22 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 27 inclusion and 16 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 24 Jun 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?

Progression-free Survival Greater Than 6 Months (time frame: At 6 months). 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 NCT00499031.

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 Jan 2015.

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