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

This study has been withdrawn prior to enrollment.
(Lack of accrual)
Sponsor:
Information provided by:
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT00620607
First received: February 7, 2008
Last updated: August 3, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms
Metastatic or Locally Advanced Gastric Cancer
Metastatic or Local Advanced GE Junction Cancer
Drug: huC242-DM4
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • response rate [ Time Frame: year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of response [ Time Frame: as necessary ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: as necessary ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: while on study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) assessment [ Time Frame: while on study ] [ Designated as safety issue: Yes ]
  • effect of huC242-DM4 on tumor uptake of FDG [ Time Frame: while on study ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: May 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: huC242-DM4
    dose of 126 mg/m2 or 168 mg/m2 given as IV once every 3 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 otherwise specified in the inclusion laboratory values.
  • Patients must have adequate organ function including:

    1. Hematopoietic:

      i. Absolute neutrophil count > 1,500/mm3. ii. Platelet count > 100,000/mm3. iii. Hemoglobin > 9 g/dL (transfusion allowed).

    2. Renal:

      i. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated creatinine clearance > 60 mL/min/1.73m2.

    3. Hepatic:

      i. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 2.5 x ULN ii. Total bilirubin ≤ 1.5 x ULN

      Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620607

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: Clinical Operations, ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT00620607     History of Changes
Other Study ID Numbers: IMGN 102
Study First Received: February 7, 2008
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
gastric

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 19, 2014