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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rutgers, The State University of New Jersey
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01407562
First received: July 20, 2011
Last updated: April 30, 2014
Last verified: April 2014

July 20, 2011
April 30, 2014
August 2011
June 2017   (final data collection date for primary outcome measure)
Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle [ Time Frame: 4 years, 6 months ] [ Designated as safety issue: Yes ]

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
Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle [ Time Frame: Up to 30 days after last dose of treatment ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01407562 on ClinicalTrials.gov Archive Site
Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib [ Time Frame: 4 years, 3 months ] [ Designated as safety issue: No ]

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

Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]

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

Not Provided
Not Provided
 
Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors
Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors

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.

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).

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Unspecified Adult Solid Tumor - Protocol Specific
  • Breast Cancer - Female
  • 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
Experimental: Pazopanib with paclitaxel and carboplatin
Interventions:
  • Drug: Pazopanib
  • Drug: Paclitaxel
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: CINJ Clinical Trials Office 732-235-8675
United States
 
NCT01407562
051101, P30CA072720
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
  • National Cancer Institute (NCI)
  • GlaxoSmithKline
Principal Investigator: Antoinette Tan, MD University of Medicine and Dentisty of New Jersey - Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP