Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: polymerase chain reaction |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors |
- Inter-individual pharmacokinetic variability [ Designated as safety issue: No ]
- Pharmacokinetic parameters [ Designated as safety issue: No ]
- Neutropenia [ Designated as safety issue: No ]
- CYP2C8*3 variant expression [ Designated as safety issue: No ]
- Genetic variance relating to pharmacokinetics and toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 129 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent.
Secondary
- To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer (castrate), metastatic breast cancer, advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel.
- To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia.
- To explore the association between the CYP2C8*3 variant and paclitaxel clearance.
- To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4, CYP3A5, SLCO1B3 (OATP8), and ABCB1 (MDR1) and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment may repeat off study every 9 weeks in the absence of disease progression or unacceptable toxicity.
Serial blood samplings are obtained at specified time points during course 1 including baseline and days 1 and 8 of course 1 for pharmacokinetic studies. Samples are also examined for genotype by PCR including variant genotypes in 2C8, CYP3A4, CYP3A5, ABCB1, ABCC2, ABCC10 and OATP1B3 genes.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00499291 History of Changes |
| Other Study ID Numbers: | CDR0000554709, ECOG-E1Y06 |
| Study First Received: | July 10, 2007 |
| Last Updated: | September 25, 2008 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer recurrent prostate cancer stage III prostate cancer stage IV prostate cancer recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer recurrent bladder cancer |
stage III bladder cancer stage IV bladder cancer recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer clear cell sarcoma of the kidney rhabdoid tumor of the kidney recurrent malignant testicular germ cell tumor stage III malignant testicular germ cell tumor recurrent cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer recurrent endometrial carcinoma stage III endometrial carcinoma |
Additional relevant MeSH terms:
|
Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013