Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pazopanib — DRUG
  pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3
• Lapatinib — DRUG
  Lapatinib in combination with pazopanib and paclitaxel in Part 3
• paclitaxel — DRUG
  in combination with pazopanib
• carboplatin — DRUG
  in combination with pazopanib

Study Details

Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.

Key Dates

Start date

Apr 28, 2006

Status verified

Nov 2017

Primary completion

Jul 21, 2009

Completion

Jul 21, 2009

Study Design

Enrollment

86 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  pazopanib and paclitaxel
• Experimental: Part 2
  pazopanib, paclitaxel, and carboplatin
• Experimental: Part 3
  pazopanib, paclitaxel, and lapatinib

Primary Outcome Measure

Adverse Effects, Laboratory parameters [ Time Frame: before and after taking the study medications. ]

Locations (3)

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