MDACC Study Summary GOG 0076DD

Study Summary
No. GOG 0076DD:.......Cervix......Robert Coleman......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG 0076DD

Study Title:	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

Physician

New Patient Referral



Name:	Robert Coleman	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:	Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	GOG/Bristol-Myers Squibb

Phase of Study:	Phase II	Return Visit:	Weekly until evidence of disease progression or unacceptable toxicity.

Treatment Agents:	Collection Cetuximab Cisplatin	Home Care:	None

Treatment Loc:	outpatient

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	05/06/2005

IRB Review and Approval Date:	03/02/2005

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	20

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:

Patients must have advanced, persistent, or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy). Histologic confirmation of the original primary tumor is required.

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 equal to or greater than 20mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or equal to or greater than 10mm when measured by spiral CT.

patients must have a least one "target lesion" to be used to assess response on this protocol as defined by RECIST (Section 8.1). 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.

Patients must have a GOG Performance Status of 0, 1, or 2.

Recovery from effective of recent surgery, radiotherapy or other therapy.

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 prior radiotherapy must be discontinued at least 4 weeks prior to registration.

Patients must have adequate: Bone marrow function: Platelet count greater than or equal to 100,000/ul, and ANC count greater than or equal to 1,500/ul, equivalent to CTCAE v3.0 grade 1.

Patients must have adequate: Renal function: creatinine less than or equal to 1.5 x institutional ULN, CTCAE v3.0 grade 1.

Patients must have adequate: Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1).

Patients must have adequate: Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1.

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

Patients must meet pre-entry requirements as specified in Section 7.0.

Patients of childbearing potential must have a negative serum pregnancy test prior to study entry (within 72 hours prior to initiation of study treatment) and be practicing an effective form of contraception.

Patients must have unstained sections from primary tumor available for submission to GOG Tissue Bank for analysis to include EGFR status.

Patients must be at least 18 years of age.

Patients must not be receiving any other investigational agent.

Exclusion Criteria:

Patients who have had prior therapy with cytotoxic drugs for cervical cancer (except when used as radiosensitizers).

Patients who have received any prior anti-epidermal growth factor receptor antibody therapy or therapy with a tyrosine kinase inhibitor that targets the EGFR pathway.

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

Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, 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 undergone major surgery, excluding diagnostic biopsy, within 30 days (to allow for full recovery) prior to registration.

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.

Links

Registration Number: