Phase I Dose Escalation Study of VELCADE Plus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

NCT ID: NCT00064636

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31

Brief Summary

The purpose of this study is to evaluate how safe VELCADE (PS-341) is when given with Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, and also to see what effects (good and bad) it has on you and your cancer.

Detailed Description

This is a dose escalation study, which means that the first group of patients who enter the study will receive a low dose of VELCADE and Docetaxel. If the low dose of VELCADE and Docetaxel appears to be safe, then the next group of patients will receive a higher dose of VELCADE and docetaxel.

Conditions

Advanced Non-Small Cell Lung Cancer; Other Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

VELCADE TM (bortezomib) for Injection, or PS-341

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has histologically-confirmed advanced and/or metastatic NSCLC or other solid tumors, for which the patient is treatment-naïve or previously received up to two anti-neoplastic treatment regimens and for whom there is no known curative therapy. Patients enrolled at the Low- and High- Dose Expanded Cohorts must have a diagnosis of NSCLC in order to be eligible.
• Previous treatment with carboplatin or paclitaxel does not preclude enrollment in the study.
• Patient has measurable or evaluable disease. Patients enrolled at the expanded cohorts must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines [1] presented in Table 3 and Table 4.
• Patient is 18 years of age or older.
• Patient has a Karnofsky performance status of 60% or higher.
• Patient has a life expectancy of three months or longer.
• Patient has all of the following pretreatment laboratory data within 21 days of the first study drug dose:
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3.
• Platelet count greater than or equal to 100,000/mm3.
• Hemoglobin greater than or equal to 8.0 g/dL.
• Serum creatinine less than or equal to 1.5 x the ULN:
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
• Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the Screening visit through 90 days after the last study drug dose.
• Male patient agrees to use an acceptable barrier method for contraception from the Screening visit through 90 days after the last study drug dose.

Exclusion Criteria

• Patient previously received treatment with docetaxel.
• Patient previously received treatment with cisplatin at a cumulative dose >350 mg/m2.
• Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
• Patient has received radiation therapy within four weeks of enrollment.
• Patient has a history of radiation therapy to >25% of bone marrow.
• Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
• Patient has had any major surgery within four weeks of enrollment.
• Patient has a history of allergic reactions to appropriate diuretics or anti-emetics to be administered in conjunction with study drug.
• Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
• Patient has electrocardiographic evidence of acute ischemia or new conduction system abnormalities.
• Patient has had a myocardial infarction within six months of enrollment.
• Patient has uncontrolled brain metastases or central nervous system disease.
• Patients with controlled brain metastases who are not receiving corticosteroids or anticonvulsants are eligible for study enrollment.
• Patient has Grade 2 or higher peripheral neuropathy
• Patient has leukemia or lymphoma.
• Patient has any of the following pretreatment laboratory data within 21 days before the first study drug dose:
• Total bilirubin > than the upper limit of normal (ULN).
• Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 x the ULN concurrent with alkaline phosphatase >2.5 x the ULN.
• Patient is HIV-infected.
• Patient is hepatitis B surface antigen positive or has previously documented hepatitis C
• Patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Female patient is pregnant or breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Other Identifiers

M34101-034

Identifier Type: -

Identifier Source: org_study_id