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Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407562
First Posted: August 2, 2011
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
GlaxoSmithKline
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose
This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

Condition Intervention Phase
Unspecified Adult Solid Tumor - Protocol Specific Breast Cancer - Female Drug: Pazopanib Drug: Paclitaxel Drug: Carboplatin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle [ Time Frame: 4 years, 6 months ]

    Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as

    1. Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted).
    2. Hematologic toxicity:

      • Grade 4 neutropenia lasting ≥ 7 days
      • Grade 4 neutropenia and fever of ≥ 38.5°C
      • ≥ Grade 3 neutropenia with ≥ Grade 3 infection
      • Grade 4 thrombocytopenia
      • Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity


Secondary Outcome Measures:
  • Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib [ Time Frame: 4 years, 3 months ]

    The first 15 patients enrolled in the dose expansion cohort will undergo PK sampling as this is felt to be an adequate sample size.

    4 blood samples (2 mL each) for the analysis of paclitaxel will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1

    2 blood samples (2 mL each) for the analysis of carboplatin will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1

    1 blood sample (2 mL) for the analysis of pazopanib will be collected in Cycle 2 Day 1



Enrollment: 34
Study Start Date: August 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib with paclitaxel and carboplatin Drug: Pazopanib
Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle
Drug: Paclitaxel
Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle
Drug: Carboplatin
Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle

Detailed Description:
This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
  • At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
  • Male or female ≥ 18 years of age
  • Able to swallow and retain oral medications

Exclusion Criteria:

  • Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
  • More than 3 prior lines of cytotoxic chemotherapy for metastatic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407562


Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
GlaxoSmithKline
Investigators
Principal Investigator: Rebecca Moss, MD Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01407562     History of Changes
Other Study ID Numbers: 051101
P30CA072720 ( U.S. NIH Grant/Contract )
NCI-2011-02448 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
First Submitted: July 20, 2011
First Posted: August 2, 2011
Last Update Posted: September 22, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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