Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Patients must have an incurable advanced or refractory tumor amenable to treatment with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)

• Per the National Comprehensive Cancer Network, the following cancer sites have been shown to be responsive to taxane therapy:

• Prostate cancer

• Breast cancer

• Non-small cell lung cancer

• Bladder cancer

• Head and neck cancer

• Oral cancer

• Cervical cancer

• Ovarian cancer

• Endometrial cancer

• Esophageal cancer

• Gastric cancer

• Germ cell tumors

• Tumors of unknown primary

• Soft tissue sarcomas

• Small cell lung cancer

• Testicular cancer

• Upper genitourinary tract cancers

PATIENT CHARACTERISTICS:

• Patients must have performance status 0-2 by the ECOG scale

• Absolute neutrophil count ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Hemoglobin ≥ 9 g/dL

• Bilirubin ≤ institutional upper limit of normal (ULN)

• ALT and AST ≤ 2.5 x ULN

• Alkaline phosphatase ≤ 2.5 x ULN (if bone metastasis is present in the absence of liver metastasis, alkaline phosphatase must be ≤ 5 x ULN)

• Creatinine ≤ 1.5 x ULN

• Patients must not have baseline sensory neuropathy ≥ grade 2

• Women must not be pregnant or breastfeeding

• Negative blood or urine pregnancy test

• Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception

PRIOR CONCURRENT THERAPY:

• Prior treatment is allowed, which may include prior taxane therapy

• If patient has had prior therapy(ies), s/he must have received last treatment ≥ 28 days prior to registration

• Patients must not be receiving colony stimulating factors (CSFs)

• Previous CSFs must have been discontinued > 14 days prior to registration

• Patients must not be receiving concomitant treatment with any of the following (prior use is allowed, but must have been discontinued ≥ 28 days prior to registration):

• Phenytoin

• Carbamazepine

• Barbiturates

• Rifampicin

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• Ketoconazole