MDACC Study Summary GOG 9918

Study Summary
No. GOG 9918:.......Cervix......Anuja Jhingran......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG 9918

Study 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

Physician

New Patient Referral



Name:	Anuja Jhingran	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:	713-563-2347 Contact us about clinical trials

General Information



Disease Group:	Cervix	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Weekly for 6 weeks of treatment, then every 3 months for 1 year post treatment.

Treatment Agents:	Cetuximab Cisplatin Radiation	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Two stays of 48 hours each for brachytherapy implants.


Description/ Intervention:	The goal of this clinical research study is to find the highest, safe dose of Cetuximab that can be given in combination with the chemotherapy drug cisplatin and radiation therapy in patients with cervical cancer. This study will also look at the effectiveness and side effects of this combination of drugs and radiation therapy.

Study Objectives / Outcomes

In this study, patients with cervical carcinoma will receive combination Cetuximab (C225) and cisplatin chemotherapy as a radiosensitizer in combination with external beam irradiation and intracavitary brachytherapy.

Primary Objectives

To determine the maximum tolerated dose or establish the safety of a biologically effective dose of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation in this patient population.
To determine the feasibility of the regimen through assessment of chronic toxicities (and possibly acute toxicities) in an expanded cohort of 20 to 40 patients.

Secondary Objectives

Estimate the distribution of progression free survival and overall survival.
To determine site of recurence, loco-regional versus distant.

Exploratory Objectives

To correlate response or progression free survival with EGF receptor expression in tumors
To correlate response or progression free survival with grade of Cetuximab induced rash.

Study Status Information



Study Activation / Registration Date:	07/22/2005

IRB Review and Approval Date:	06/01/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	30-100

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 with histologically confirmed advanced cervical cancer (any cell type): FIGO Clinical stages 1B, IIA, IIB, IIIA, IIIB, IVA, with positive or negative pelvic and/or para-aortic lymph nodes by radiological evaluation. Patients enrolled on this trial will not have undergone primary surgical therapy for their disease. Only those with previously untreated, curable but inoperable disease will be included.

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

3) Patients must have adequate: BONE MARROW FUNCTION: Absolute neutrophil count (ANC) = to or >1,500mcl, equivalent to CTCAE v3.0 grade 1. Platelets = to or >100,000/mcl, CTCAE v 3.0 grade 0-1. RENAL FUNCTION: Creatinine < or = to institutional upper limit normal (ULN), CTCAE v3.0 grade 0. NOTE: If creatinine >ULN, creatinine clearance must be >50 mL/min. HEPATIC FUNCTION: Bilirubin < or = to 1.5 x ULN, CTCAE v3.0 grade 1. SGOT and alkaline phosphatase < or = to 2.5 x ULN, CTCAE v3.0 grade 0-1. NEUROLOGIC FUNCTION: Neuropathy (sensory and motor) < or = to CTCAE v3.0 grade 1.

4) Patients with ureteral obstruction mjust undergo stent or nephrostomy tube placement prior to study entry.

5) Patients must meet the pre-entry requirements: history & physical, toxicity assessment, tumor measurement, CT scan of chest, abdomen, pelvis for patients with measurable disease, CBC/Differential/Platelets, Electrolytes, BUN, Creatinine, CrCl, Ca,Mg, PO4, Bilirubin, SGOT, Alkaline Phosphatase, LDH, EKG, audiogram (if history of hearing loss), pregnancy test (if of child-bearing potential). Other optional tests: barium enema, proctoscopy, cystoscopy, renal ultrasound.

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

7) Patients of child-bearing 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. Women should not breast-feed while on this study.

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

9) Patients must be at least 18 years of age.

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

Exclusion Criteria:

1) Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.

2) Patients with septicemia or severe infection.

3) Patients who have circumstances that will not permit completion of this study or the required follow-up.

4) Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields.

5) 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.

6) Patients with history of chimerized or murine monoclonal antibody therapy.

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, congestive heart failure, or uncontrolled arrhythmias with 6 months of registration.

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

10) Patients with history of active collagen vascular disease.

Links

Registration Number: NCT00104910
Study Information on Clinical Trials Registry (clinicaltrials.gov)