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Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00101192
Enrollment
76
Registered
2005-01-10
Start date
2004-09-30
Completion date
Unknown
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical small cell carcinoma, cervical squamous cell carcinoma, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

Brief summary

RATIONALE: 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. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. 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. Giving cetuximab together with cisplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Detailed description

OBJECTIVES: Primary * Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix. * Determine the nature and degree of toxicity of this regimen in these patients. Secondary * Determine the progression-free survival and overall survival of patients treated with this regimen. * Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Interventions

BIOLOGICALcetuximab
DRUGcisplatin

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Bristol-Myers Squibb
CollaboratorINDUSTRY
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed squamous or non-squamous cell carcinoma of the cervix * Advanced, persistent, or recurrent disease * Documented disease progression * Not amenable to curative therapy * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No significant history of cardiac disease within the past 6 months, including the following: * Unstable angina * Uncontrolled hypertension * Uncontrolled congestive heart failure * Uncontrolled arrhythmia Neurologic * No uncontrolled seizure disorder * No active neurological disease * No neuropathy (sensory and motor) \> grade 1 Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-epidermal growth factor receptor (EGFR) antibody therapy * No prior chimerized or murine monoclonal antibody therapy Chemotherapy * Not specified Endocrine therapy * At least 1 week since prior anticancer hormonal therapy * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery * More than 30 days since prior major surgery, except diagnostic biopsy Other * Recovered from all prior therapy * No prior cytotoxic therapy for cervical cancer * No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway * No prior cancer treatment that would contraindicate study therapy * No other concurrent investigational agents

Design outcomes

Primary

MeasureTime frameDescription
Tumor Responseup to 6 months from study entryPer GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): 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): 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. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: 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: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Secondary

MeasureTime frame
Progression-free Survival and Overall Survival at 6 Months After Completion of Treatmentup to 5 years from study entry

Countries

United States

Participant flow

Participants by arm

ArmCount
Cetuximab
Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
69
Total69

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyIneligible6
Overall StudyInevaluable1

Baseline characteristics

CharacteristicCetuximab
Age, Continuous50.8 years
STANDARD_DEVIATION 11.2
Age, Customized
20-29 years
1 participants
Age, Customized
30-39 years
11 participants
Age, Customized
40-49 years
18 participants
Age, Customized
50-59 years
26 participants
Age, Customized
60-69 years
9 participants
Age, Customized
70-79 years
4 participants
Cell Type
Adenocarcinoma, Unspecified
21 participants
Cell Type
Adenosquamous
5 participants
Cell Type
Clear Cell Carcinoma
1 participants
Cell Type
Mucinous Adenocarcinoma
1 participants
Cell Type
Squamous Cell Carcinoma
41 participants
Region of Enrollment
United States
69 participants
Sex: Female, Male
Female
69 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
66 / 69
serious
Total, serious adverse events
33 / 69

Outcome results

Primary

Tumor Response

Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): 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): 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. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: 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: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Time frame: up to 6 months from study entry

Population: Eligible and evaluable participants

ArmMeasureGroupValue (NUMBER)
CetuximabTumor ResponseComplete Response1 participants
CetuximabTumor ResponsePartial Response7 participants
CetuximabTumor ResponseIncreasing Disease17 participants
CetuximabTumor ResponseStable Disease34 participants
CetuximabTumor ResponseIndeterminate10 participants
Secondary

Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment

Time frame: up to 5 years from study entry

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026