MDACC Study Summary 2007-0224 (Archived)

Study Summary
No. 2007-0224:.......Esophageal; Gastric......Alexandria T. Phan......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2007-0224

Study Title:	A phase II, Open Label, Multiple Center Study of huC242-DM4 Given as an Intravenous Infusion Once Every Three Weeks to Patients with Metastatic Gastric or Gastroesophageal Junction Carcinomas (102)

Physician

New Patient Referral



Name:	Alexandria T. Phan	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Esophageal Gastric	Supported By:	ImmunoGen, Inc.

Phase of Study:	Phase II	Return Visit:	Patients return to MDACC on days 1, 8 and 15 of cycles 1 and 2, and days 1 and 15 for all subsequent cycles. After cycle 2, day 8 labs may be done at a lab close to the patient's home and the toxicity and conmed review may be performed by telephone.

Treatment Agents:	huC242-DM4	Home Care:	No home care is required for this protocol

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

Estimated Length of Stay in Houston:	This protocol does not required hospital stays


Description/ Intervention:	The goal of this clinical research study is to learn if treatment with huC242-DM4 can help shrink or slow the growth of the disease in patients with stomach cancer or cancer of the connection between the stomach and esophagus. The safety and side effects of this treatment will also be studied.

Study Objectives / Outcomes

Primary Objective:
To assess the response rate of huC242-DM4 given as a single intravenous infusion at 126 mg/m² once every three weeks to patients who have metastatic or locally advanced gastric and gastroesophageal junction cancer and have low plasma CanAg levels (< 1000 U/ml). An exploratory assessment of response rate in patients with high CanAg levels (=/>1000 U/ml) treated with huC242-DM4 given as a single intravenous infusion at 168 mg/m² once every three weeks will also be performed.

Secondary Objectives:

To assess duration of response.

To assess progression free survival.

To evaluate safety and tolerability of huC242-DM4 administered on this schedule in the study population.

To assess Pharmacokinetics of huC242-DM4 in this patient population.

To assess the effect of huC242-DM4 on tumor uptake of

¹⁸

FDG.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/21/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	55

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 understand and voluntarily sign an informed consent.

2) Patients must have histological documentation of metastatic or locally advanced (American Joint Committee on Cancer Staging System: Stages IIIA, IIIB, and IV) gastric or gastroesophageal junction adenocarcinoma.

3) Patients must have ECOG performance status </= 1.

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

5) Patients who have been treated with only one prior chemotherapy regimen and who have documented disease progression. Patients who have received more than 1 prior chemotherapy regimens with documented disease progression may be allowed only if patients have good performance status (ECOG < 1) and upon agreement between the investigator and the ImmunoGen medical monitor. Adjuvant chemotherapy will not be considered as a prior chemotherapy regimen unless it is completed less than 6 months prior to enrolment.

6) Patients must have confirmation of CanAg expression performed prior to enrollment by immunohistochemical assessment for CanAg on archived biopsy samples. CanAg positive gastric or gastroesophageal junction carcinomas are defined as having heterogeneous (25 - 75% of tumor cells stain positively for CanAg) or homogeneous staining of tumor cells (>75% of tumor cells are positive for CanAg) when evaluated by immunohistochemistry on the archived biopsy samples.

7) Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be at least 20 mm by conventional radiologic techniques or at least 10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion.

8) Patients with reproductive potential must agree to use an effective contraceptive method during the study and for 30 days after receiving the last dose of study drug.

9) Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within one week prior to enrollment in the study.

10) Patients must have any chemotherapy, immunotherapy, hormonal therapy, radiotherapy for cancer or surgery (except for minor surgical procedures) completed at least 3 weeks before starting study medication.

11) Patients must have resolution of all clinically significant toxic effects (excluding alopecia) of any prior treatments including surgery, radiotherapy, hormone therapy, immunotherapy, targeted non-cytotoxic therapy, or chemotherapy to grade </= 1 by NCI CTCAE v. 3.0 unless specified in the inclusion laboratory values.

12) Patients must have adequate organ function including:Hematopoietic:Absolute neutrophil count >/= 1,500/mm^3; Platelet count >/=100,000/mm^3; Hemoglobin >/= 9g/dL (transfusion allowed). Renal:Serum creatinine </=1.5 x the upper limit of normal(ULN); Calculated creatinine clearance >/= 60 mL/min/1.73m^2.*; Hepatic:Alanine aminotransferase(ALT), or aspartate aminotransferase(AST) </=2.5 x ULN; Total bilirubin </=1.5 x ULN; *Calculated by Cockroft and Gault method. Creatinine clearance (mL/min)=(140-age)x weight (kg)/72 x (serum creatinine in mg/dL)=mL*/min (*for females, multiply results by 0.85)

Exclusion Criteria:

1) Pregnant or lactating women. Women of childbearing potential (WCBP) must have a negative urine or blood test for pregnancy before first treatment.

2) Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.

3) Active and uncontrolled infection.

4) Known history of hepatitis B or C , HIV, or history of alcoholic liver disease.

5) Patients with any serious medical or psychiatric disorder that would interfere with patient safety or informed consent.

6) Patients with peripheral neuropathy grade 2 or greater.

7) Patients with known leptomeningeal disease or progressive brain metastasis. Routine screening with CNS imaging studies (CT or MRI) is required only if clinically indicated.

8) Patients with concomitant malignancies or previous malignancies with less than a 2 year disease free interval at the time of dosing. Patients with adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low-grade prostate cancer may enroll irrespective of the time of diagnosis.

9) Patients who are receiving concomitant chemotherapy, immunotherapy, radiotherapy, or investigational therapy. Radiotherapy for palliation of related bone metastases is permitted upon the agreement of the investigator and the ImmunoGen Medical Monitor and as long as radiation does not involve target lesions that are followed for drug treatment response evaluation.

10) Patients with any severe concurrent disease or condition, which in the judgment of the Investigator, would make the patient inappropriate for study participation. The disease or condition includes, but not limited to, one or more of the following: bleeding diathesis, uncontrolled chronic kidney or liver disease, uncontrolled diabetes, history of cardiac disease, myocardial infarction within the past 6 months, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and uncontrolled hypertension.

11) Patients who must use contact lenses and cannot discontinue use of their contact lenses during the course of the clinical study. Patients must discontinue use of contact lenses prior to receiving study drug.

Links

Registration Number: NCT00620607
Study Information on Clinical Trials Registry (clinicaltrials.gov)