MDACC Study Summary GOG 0227E

Study Summary
No. GOG 0227E:.......Cervix......Lois M. Ramondetta......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG 0227E

Study Title:	A Phase II Evaluation of Cetuximab (ERBITUXŽ, C225, NSC# 714692) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

Physician

New Patient Referral



Name:	Lois M. Ramondetta	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0307 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	Bristol Myers Squibb Oncology Gynecologic Oncology Group

Phase of Study:	Phase II	Return Visit:	Weekly until disease progression or adverse effects prohibit further therapy

Treatment Agents:	Cetuximab	Home Care:	none

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary Objective
1. To assess the activity of cetuximab for patients with persistent or recurrent carcinoma of the cervix with 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.
2. To determine the effect of cetuximab on the duration of objective response in persistent or recurrent carcinoma of the cervix.
3. To determine the nature and degree of toxicity of cetuximab as assessed by CTCAE v3.0 in this cohort of patients.

Exploratory Objectives
1. To determine the proportion of patients with advanced, persistent, or recurrent cancer of the cervix whose tumors over express epidermal growth factor receptor (EGFR).
2. To determine the association between EGFR expression and tumor characteristics and measures of clinical outcome including rate of progression-free survival, objective response rate, overall survival, and objective response duration in this patient population.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/22/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	19-34

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) All patients must have measurable disease. Measurable disease is 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, and MRI, or >/= 10 mm when measured by spiral CT.

3) Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.

4) 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 fo the same patient population.

5) Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Patients who have received two prior regimens must have a GOG Performance Status of 0 or 1.

6) Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. Patients should be free of active infection requiring antibiotics. 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.

7) 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 radio-sensitizer is not counted as a systemic chemotherapy regimen.

8) 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.

9) (Cont from # 8) NOTE: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent cervical disease, as defined above. However, due to the novel nature of biologic compunds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy.

10) Patients must have adequate: bone marrow function: platelet count >/= 100,000/mcl and ANC count >/= 1,500/mcl, equivalent to CTCAE v3.0 grade 1; renal function: creatinine </= 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1; hepatic function: Bilirubin </= 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase </= 2.5 x ULN (CTCAE v3.0 grade 1); neurologic function: neuropathy (senssory and motor) ,</= CTCAE v3.0 grade 1; calcium levels: calcium level ,</= 11.0 mg/dl.

11) Patients must have signed an approved informed consent and authorization permitting release of personal health information.

12) Patients must meet pre-entry requirements.

13) 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.

14) Patients must be AT LEAST 18 years of age. The safety and effectiveness of cetuximab in pediatric patients have not been established.

15) Patients must not be receiving any other investigational agent.

Exclusion Criteria:

1) Patients who have received prior therapy with cetuximab or any other anti-epidermal growth factor receptor antibody.

2) Patients who have received any prior therapy with a tyrosine kinase inhibitor that targets the EGFR pathway.

3) Patients who have received any prior chimerized or murine monoclonal antibody therapy.

4) Patients with a history of other invasive malignancies, with the exception of non-melanoma 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.

5) 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.

6) 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.

7) Patients who have undergone major surgery, excluding diagnostic biopsy, within 30 days (to allow for full recovery) prior to registration.

8) 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.

9) Patients who have an uncontrolled seizure disorder, or active neurological disease.

10) Patients with craniospinal metastases.

11) Patients known to be seropositive for HIV and/or active hepatitis, even if liver function studies are in the eligible range.

12) Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator.

13) Known hemorrhagic diathesis or active bleeding disorder.

Links

Registration Number: NCT00499031
Study Information on Clinical Trials Registry (clinicaltrials.gov)