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

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. Identifier: NCT00388076
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: Pazopanib Drug: Lapatinib Drug: paclitaxel Drug: carboplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of Pazopanib in Combination With Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28-Day Cycle, Paclitaxel and Carboplatin on an Every 21 Days Schedule and Lapatinib and Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28- Day Cycle
Actual Study Start Date : April 28, 2006
Actual Primary Completion Date : July 21, 2009
Actual Study Completion Date : July 21, 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part 1
pazopanib and paclitaxel
Drug: Pazopanib
pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3

Drug: paclitaxel
in combination with pazopanib
Other Name: TAXOL

Experimental: Part 2
pazopanib, paclitaxel, and carboplatin
Drug: Pazopanib
pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3

Drug: paclitaxel
in combination with pazopanib
Other Name: TAXOL

Drug: carboplatin
in combination with pazopanib

Experimental: Part 3
pazopanib, paclitaxel, and lapatinib
Drug: Pazopanib
pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3

Drug: Lapatinib
Lapatinib in combination with pazopanib and paclitaxel in Part 3

Drug: paclitaxel
in combination with pazopanib
Other Name: TAXOL

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

Secondary Outcome Measures :
  1. Blood samples [ Time Frame: over a 24 hour period ]
  2. Tumors [ Time Frame: will be measured at routine intervals throughout (e.g. by CT scan). ]

Information from the National Library of Medicine

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

Inclusion criteria:

  • Confirmed diagnosis of cancer, except cervical cancer
  • Eastern Cooperative Oncology Group performance Status of 0 or 1
  • Peripheral neuropathy of Grade 1 or less
  • Adequate bone marrow function (absolute neutrophils, platelets and hemoglobin levels as per protocol)
  • Adequate renal function as per protocol
  • Urine creatinine ratio as per protocol
  • Adequate hepatic function as per protocol
  • Coagulation tests as per protocol
  • Male of female at least 18 years of age
  • A woman is eligible to enter and participate in the study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any woman who:
  • Has had a hysterectomy,
  • Has had a bilateral oophorectomy (ovariectomy),
  • Has had a bilateral tubal ligation,
  • Is post-menopausal (total cessation of menses for at least 1 year)
  • Childbearing potential, has a negative serum or urine pregnancy test at screening, and agrees to one of the following:
  • An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the patient's entry and is the sole sexual partner for that woman.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, throughout the clinical trial, and for at least 21 days after the last dose of investigational product.
  • Double-barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR male condom and diaphragm.
  • Predicted life expectancy of at least 12 weeks
  • Written informed consent
  • Able to swallow and retain oral medications.

Exclusion criteria:

  • No more than 3 prior lines of cytotoxic chemotherapy for metastatic disease are allowed.
  • No major surgery, nor cytotoxic chemotherapy, investigational agents, or radiotherapy within the last 28 days and subject must have recovered fully from whatever their last treatment was at the time of enrollment.
  • Women who are pregnant or breast feeding are not eligible to enroll.
  • Cannot have poorly controlled hypertension.
  • Cannot have corrected QT (QTc) prolongation
  • Cannot have Class III or IV heart failure as defined by the New York Heart Association functional classification system.
  • Cannot have arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months.
  • Cannot use of therapeutic warfarin.
  • Cannot have history of bleeding (hemoptysis, hematuria, GI blood loss, epistaxis, or others with greater than Grade 1 according to CTC Criteria) within six weeks prior to beginning therapy or any clinical indications of current active bleeding or bleeding diathesis.
  • Cannot have history or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to beginning study treatment.
  • Cannot have any serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining consent.
  • Cannot have history of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of pazopanib, paclitaxel, or carboplatin. Has any unresolved bowel obstruction or diarrhea. Has clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:

    • active peptic ulcer disease,
    • known intraluminal metastatic lesion(s) with suspected bleeding,
    • inflammatory bowel disease including ulcerative colitis, or other GI conditions with increased risk of perforation,
    • history of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
  • Subject must not have psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Subject must not take any specifically prohibited medication specified in the protocol during the study or requires any of these medications during treatment with pazopanib.
  • Subject must not have clinical history, current alcohol or illicit drug use which, in the judgment of the Investigator, would interfere with the patient's ability to comply with the dosing schedule and protocol-specified evaluations.
  • Subject must not be allergic to either TAXOL or PARAPLATIN, or any other taxane or platinum containing compound.
  • Subject must not have a current diagnosis of cervical cancer.
  • Subject must not have known endobronchial metastasis or involvement of large pulmonary vessel(s) by tumor.

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 identifier (NCT number): NCT00388076

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United States, New Jersey
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline Identifier: NCT00388076    
Other Study ID Numbers: VEG105427
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors