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Cervical AdenocarcinomaPhase 1NCT00104910

Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

A Phase 1 study testing Internal Radiation Therapy, 3-Dimensional Conformal Radiation Therapy and Cetuximab in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 15 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 I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Internal Radiation Therapy, 3-Dimensional Conformal Radiation Therapy and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
15 sitesUnited States
Study dates
Jan 2005to Jan 2013
Phase
Phase 1
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 cervical cancer
  • Clinical stage IB-IVA disease
  • Any cell type allowed
  • Positive or negative pelvic and/or para-aortic lymph nodes by radiography
  • Unstained sections from primary tumor available
  • Performance status - GOG 0-1
Show all 40Show fewer
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine normal
  • Creatinine clearance > 50 mL/min
  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
  • No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields
  • No significant cardiac disease within the past 6 months, including any of the following:
  • Uncontrolled hypertension
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sensory or motor neuropathy > grade 1
  • No septicemia
  • No severe infection
  • No circumstance that would preclude study participation or follow-up
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No uncontrolled seizure disorder
  • No active neurologic disease
  • No history of active collagen vascular disease
  • No prior chimerized or murine monoclonal antibody therapy
  • No prior cytotoxic chemotherapy for cervical cancer
  • No prior pelvic or abdominal radiotherapy for cervical cancer
  • No concurrent intensity modulated radiotherapy
  • No prior renal transplantation
  • More than 30 days since prior major surgery (excluding diagnostic biopsy)
  • No other prior therapy for cervical cancer
  • No prior cancer treatment that would preclude study therapy
  • No other concurrent investigational agents

Who cannot join

None listed.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Georgia Regents University Medical Center

    Augusta, Georgia, 30912

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: A Phase I Trial of Tailored Radiation Therapy With Concomitant Cetuximab (C225, NSC #714692) and Cisplatin (NSC #119875) in the Treatment of Patients With Cervical Cancer

This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA 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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose or safe biologically effective dose of cetuximab when administered in combination with cisplatin, external beam radiotherapy, and brachytherapy in patients with stage IB-IVA cervical cancer.

II. Determine the feasibility of this regimen, in terms of chronic and acute toxic effects, in these patients.

SECONDARY OBJECTIVES:

  1. Determine the distribution of progression-free survival and overall survival of patients treated with this regimen at 1 year after study entry.

II. Determine the site of recurrence (locoregional vs distant) in patients treated with this regimen up to 1 year after study entry.

III. Correlate response or progression-free survival with epidermal growth factor receptor expression in tumor samples from patients treated with this regimen at 1 year after study entry.

IV. Correlate response or progression-free survival with grade of cetuximab-induced rash in patients treated with this regimen at 1 year after study entry.

OUTLINE: This is a multicenter, dose-escalation study of cetuximab. Patients are stratified according to nodal status (positive para-aortic and/or pelvic lymph nodes vs negative para-aortic and pelvic lymph nodes).

Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment within 8 weeks.

Cohorts of 3-6 patients per stratum receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

Being tested
Internal Radiation Therapy, 3-Dimensional Conformal Radiation Therapy, Cetuximab, Cisplatin
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.

  • Internal Radiation TherapyRadiation

    Also called Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3D-CRT, Conformal Therapy, Radiation Conformal Therapy

  • CetuximabBiological

    Also called Chimeric MoAb C225, Erbitux, IMC-C225

    Given IV

  • CisplatinDrug

    Given IV

Study groups in NCT00104910
Study groupRoleWhat they receive
Treatment (brachytherapy, radiation, cetuximab, cisplatin)ExperimentalPatients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Internal Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Biological: Cetuximab; Drug: Cisplatin

What is being measured

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

  1. Maximum tolerated dose (MTD) or biologically effective dose (BED) of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation, graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

    Evaluation of the regimens will be conducted separately by the type of radiation received (extended field radiation or whole pelvis radiation).

    Measured: 6 weeks

  2. Incidence of toxicities at the MTD, assessed by CTCAE v3.0

    Measured: Up to 1 year

Secondary outcomes (3)

  1. Progression-free survival

    Measured: From study entry until disease progression, death or date of last contact, up to 1 year

  2. Site of recurrence, loco-regional vs distant, assessed by clinical and radiological evaluation

    Measured: From study entry until disease progression, death or date of last contact, up to 1 year

  3. Frequency of chronic toxicities, assessed by CTCAE v3.0

    Measured: From study entry until disease progression, death or date of last contact, up to 1 year

Timeline

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

  1. First posted4 Mar 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionJan 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104910
Sponsor's protocol ID
GOG-9918
Other IDs
NCI-2009-00621, CDR0000413880, GOG-9918, GOG-9918, GOG-9918, U10CA027469
Status last verified
Dec 2014
First submitted
3 Mar 2005
Last updated
31 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Internal Radiation Therapy, 3-Dimensional Conformal Radiation Therapy and Cetuximab in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 15 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 40 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 31 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 15 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Maximum tolerated dose (MTD) or biologically effective dose (BED) of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation, graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) (time frame: 6 weeks). 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 NCT00104910.

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 31 Dec 2014.

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