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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00388076
First received: October 11, 2006
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

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 Intervention Phase
Solid Tumor Cancer
Neoplasms, Breast
Drug: Pazopanib
Drug: Lapatinib
Drug: paclitaxel
Drug: carboplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 3 Consecutive Wks, Paclitaxel & Carboplatin on an Every 21 Days Schedule and Lapatinib & Paclitaxel on a Weekly Schedule for 3 Consecutive Weeks

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 86
Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Pazopanib
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
Other Name: Pazopanib
Drug: paclitaxel
in combination with pazopanib
Other Name: TAXOL
Drug: carboplatin
in combination with pazopanib
Other Name: PARAPLATIN
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
Other Name: Pazopanib
Drug: Lapatinib
Lapatinib in combination with pazopanib and paclitaxel in Part 3
Drug: paclitaxel
in combination with pazopanib
Other Name: TAXOL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00388076

Locations
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Tan AR, Dowlati A, Jones SF, Infante J, Nishioka J, Fang L, Hodge JP, Gainer SD, Arumugham T, Suttle AB, Lager JJ, Burris HA III. Phase I Study of Pazopanib in Combination with Weekly Paclitaxel in Patients with Advanced Solid Tumors. [Oncologist]. 2010;15(12):1253-1261.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00388076     History of Changes
Other Study ID Numbers: VEG105427
Study First Received: October 11, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pazopanib
paclitaxel
carboplatin
lapatinib
TAXOL
TYKERB
PARAPLATIN

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

ClinicalTrials.gov processed this record on November 27, 2014