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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
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407562

Contacts
Contact: CINJ Clinical Trials Office 732-235-8675

Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
GlaxoSmithKline
Investigators
Principal Investigator: Antoinette Tan, MD University of Medicine and Dentisty of New Jersey - Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01407562     History of Changes
Other Study ID Numbers: 051101, P30CA072720
Study First Received: July 20, 2011
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014