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Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Pemetrexed in Treating Patients With Advanced Non-Small Cell Lung Cancer, Breast Cancer, or Other Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: May 3, 2007   Last Updated: December 23, 2008   History of Changes
Sponsors and Collaborators: University of California, Davis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470548
  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. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: pemetrexed disodium
Phase I
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Lung Cancer
Drug Information available for: Paclitaxel Pemetrexed Pemetrexed disodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety (phase I) [ Designated as safety issue: Yes ]
  • Efficacy, as measured by objective tumor response rate (phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum tolerated dose (phase I) [ Designated as safety issue: Yes ]
  • Progression-free survival (phase II) [ Designated as safety issue: No ]
  • Overall survival (phase II) [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: April 2007
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and feasibility of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
  • Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)

Secondary

  • Determine the maximum tolerated dose of this regimen in these patients. (Phase I)
  • Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
  • Determine the progression-free survival and overall survival of patients treated with this regimen. (Phase II)
  • Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.

  • Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized nanoparticle formulation at the MTD as in phase I.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Cytologically or histologically proven advanced non-small cell lung cancer (NSCLC), breast cancer, or other solid tumors (phase I)

    • Evaluable disease (i.e., bone metastases, pleural fluid, ascites) allowed
  • Cytologically or histologically proven NSCLC, meeting all of the following criteria (phase II):

    • Stage IIIB (pleural effusion) or IV disease

      • NSCLC that has progressed or recurred after first-line therapy for stage IIIA or IIIB disease allowed
    • Progressed or recurred after prior platinum-based therapy
    • Stable disease as best response to first-line therapy allowed
    • Must have measurable disease by RECIST criteria

      • Disease in previously irradiated sites is considered measurable if there is clear disease progression after radiotherapy
  • No third space fluid which cannot be controlled by drainage
  • Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) are eligible provided they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • Zubrod performance status (PS) 0-2 (phase I) or 0-1 (phase II)
  • Life expectancy ≥ 3 months
  • Creatinine clearance ≥ 45 mL/min
  • AST and ALT < 2.5 times upper limit of normal
  • Bilirubin normal
  • Platelet count ≥ 100,000/mm³
  • ANC ≥ 1,500/mm³
  • Must be able to take and retain oral medication
  • Must be able to take folic acid, vitamin B12, and dexamethasone
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No preexisting peripheral neuropathy ≥ grade 2
  • No other active malignancy
  • No other clinically significant illness
  • No other serious medical or psychiatric illness, including serious active infection
  • No history of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, pemetrexed disodium, or a taxane
  • No serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • No NSAIDS for 2 days before (5 days for long acting NSAIDS), during, and for 2 days after pemetrexed disodium
  • At least 2 weeks since prior radiotherapy
  • At least 4 weeks since prior chemotherapy
  • Any number of prior chemotherapy regimens allowed (phase I)
  • No more than 2 prior chemotherapy regimens for advanced NSCLC (phase II)

    • Patients with recurrent stage III disease may have had ≤ 2 prior treatments (including primary therapy, adjuvant therapy, or concurrent chemoradiotherapy)
  • No prior paclitaxel
  • No prior paclitaxel albumin-stabilized nanoparticle formulation
  • No prior pemetrexed disodium
  • No other concurrent chemotherapy, biologic therapy, or targeted therapies
  • No other concurrent anticancer or investigational therapy
  • No concurrent radiotherapy
  • No concurrent enrollment in another clinical study in which investigational procedures are performed or investigational therapies are administered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470548

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
Sponsors and Collaborators
University of California, Davis
Investigators
Study Chair: David R. Gandara, MD University of California, Davis
Investigator: Corinne Turrell, CCRP University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California Davis Cancer Center ( David R. Gandara )
Study ID Numbers: CDR0000542904, UCD-185, UCD-200614714
Study First Received: May 3, 2007
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00470548     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Skin Diseases
Breast Neoplasms
Antimitotic Agents
Breast Cancer, Male
Folic Acid Antagonists
Recurrence
Carcinoma
Folic Acid
Pemetrexed
Breast Neoplasms, Male
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Pharmacologic Actions
Carcinoma
Pemetrexed
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009