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A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-colorectal Cancer, Pancreatic Cancer

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Trial Information

A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors


OBJECTIVES:

Primary

- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid
DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or
metastatic colorectal cancer, pancreatic cancer, or other solid tumors.

Secondary

- Determine the qualitative and quantitative toxicities of this drug in these patients.

- Characterize the pharmacokinetics of this drug in these patients.

- Describe any antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation study.

Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over
4-5 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized
monoclonal antibody huC242 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose-limiting
toxicity. Up to 15 patients are treated at the MTD.

Patients undergo blood collection at baseline and periodically during study for
pharmacokinetic studies.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor

- Inoperable or metastatic disease

- Failed standard therapy

- Confirmed cancer antigen (CanAg) expression

- Patients must have non-colorectal cancer or pancreatic cancer

- Tumor must have a homogeneous pattern (i.e., staining present in > 75% of tumor
cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry * No known
leptomeningeal disease or progressive brain disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Absolute neutrophil count ≥ 1,500/mm³

- Hemoglobin ≥ 9 g/dL (transfusion allowed)

- Platelet count ≥ 100,000/mm³

- aPTT and INR ≤ 1.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT < 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No hypersensitivity to agents of the same class as the study drug, humanized or
nonhumanized antibodies, or immunoconjugates

- No active, uncontrolled infection

- No hepatitis B surface antigen or hepatitis C antibody positivity

- No history of alcoholic liver disease

- No serious medical or psychiatric disorder that would preclude compliance with study
requirements

- No peripheral neuropathy > grade 1

- No other malignancy within the past 2 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade
prostate cancer

- No severe concurrent disease or condition that, in the opinion of the investigator,
would preclude study participation

PRIOR CONCURRENT THERAPY:

- Recovered from prior therapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C)

- At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for
cancer

- At least 4 weeks since prior major surgery

- No concurrent chemotherapy, other immunotherapy, radiotherapy, or other
investigational therapy

- Palliative radiotherapy for related bone metastases allowed

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Time Frame:

for the duration of the trial

Safety Issue:

Yes

Principal Investigator

Alain Mita, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institute for Drug Development

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000491224

NCT ID:

NCT00352131

Start Date:

February 2005

Completion Date:

December 2009

Related Keywords:

  • Non-colorectal Cancer
  • Pancreatic Cancer
  • unspecified adult solid tumor, protocol specific
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
UT Health Science CenterSan Antonio, Texas  78245-3217