huC242-DM4 Treating Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas

NCT00620607 | Withdrawn Phase 2

• 1 other identifier: IMGN 102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with metastatic or locally advanced gastric or gastroesophageal junction cancer.

Conditions

Stomach Neoplasms; Metastatic or Locally Advanced Gastric Cancer; Metastatic or Local Advanced GE Junction Cancer

Keywords

gastric

Outcome Measures

Primary Outcomes (1)

• response rate

  year

Secondary Outcomes (5)

• duration of response

  as necessary

• progression free survival

  as necessary

• safety and tolerability

  while on study

• Pharmacokinetic (PK) assessment

  while on study

• effect of huC242-DM4 on tumor uptake of FDG

  while on study

Interventions

huC242-DM4 DRUG

dose of 126 mg/m2 or 168 mg/m2 given as IV once every 3 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must understand and voluntarily sign an informed consent.
• 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.
• Patients must have ECOG performance status \< 1.
• Patients must be at least 18 years of age.
• Patients who have been treated with only one prior chemotherapy regimen and who have documented disease progression.
• Patients must have confirmation of CanAg expression performed prior to enrollment by immunohistochemical assessment for CanAg on archived biopsy samples.
• 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 radiological 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.
• 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.
• Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within one week prior to enrollment in the study.
• 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.
• Patients must have adequate organ function including:
• Hematopoietic:
• i. Absolute neutrophil count \> 1,500/mm3. ii. Platelet count \> 100,000/mm3. iii. Hemoglobin \> 9 g/dL (transfusion allowed).
• Renal:
• i. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated creatinine clearance \> 60 mL/min/1.73m2.

You may not qualify if:

• Pregnant or lactating women. Women of childbearing potential (WCBP) must have a negative urine or blood test for pregnancy before first treatment.
• Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.
• Active and uncontrolled infection.
• Known history hepatitis B or C, HIV, or history of alcoholic liver disease.
• Patients with any serious medical or psychiatric disorder that would interfere with patient safety or informed consent.
• Patients with peripheral neuropathy grade 2 or greater.
• Patients with known leptomeningeal disease or progressive brain metastasis. Routine screening with CNS imaging studies (CT or MRI) is required only if clinically indicated.
• 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.
• Patients who are receiving concomitant chemotherapy, immunotherapy, radiotherapy, or investigational therapy. Radiotherapy for palliation of related bone metastases is permitted upon the agreement between 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.
• 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 include, but are 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.
• 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.

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (4)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

U.T. M.D. Anderson Cancer Center

Houston, Texas, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 26, 2015

Record last verified: 2009-04

Locations

US (4)