Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumors

• Advanced metastatic disease

• Measurable or evaluable disease

• Must meet 1 of the following criteria:

• Failed prior standard therapy

• Not a candidate for standard therapy

• Has a disease for which there is no defined standard therapy

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• ECOG functional status 0-2

• Life expectancy ≥ 8 weeks

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• Bilirubin normal

• Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min

• AST and ALT ≤ 2.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride

• No active infectious process that will require treatment with antibiotics for > 4 weeks

• No uncontrolled congestive heart failure

• No symptomatic coronary artery disease or heart block

• No myocardial infarction within the past 3 months

• No peripheral neuropathy ≥ grade 2 from any cause

PRIOR CONCURRENT THERAPY:

• More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment

• No prior radiotherapy to > 25% of bone marrow

• No prior nitrosoureas

• No more than 6 prior courses of alkylating agents

• No more than 2 prior courses of mitomycin C

• No more than 3 prior courses of cytotoxic therapy for metastatic disease

• No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1