A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

NCT01542047 | Terminated Phase 1 DMC

• 3 other identifiers: INST 1015PZP114405NCI-2012-00915
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the possibility that use of two similar but distinct drugs used together in treatment of advanced cancer might prove less toxic than either agent used alone, because dosages can be reduced for each agent. This is a phase I study that is designed to measure the frequency and levels of specific side effects when Carboplatin and Pazopanib are used in combination in advanced cancer patients. The possibility that anti-tumor activity will occur is also going to be investigated.

Conditions

Cancer, Metastatic

Keywords

Metastatic; Solid tumors; carboplatin; Paraplatin; Pazopanib; Votrient; Alkylating agent; Tyrosine kinase inhibitor; Metastatic disease

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of Pazopanib when used in combination with Carboplatin

  Patients will receive 200mg of Pazopanib, with later subjects receiving higher dosages up to 800mg of Pazopanib. If a given dose level is not well tolerated when given on all days (1-21) of each cycle, the study will no longer use that dosage. Later subjects may take Pazopanib from days 3-19 of the three week cycle to see if that dosing schedule is better tolerated. If patients experience side effects from Pazopanib or tests indicate some undesirable effects, then the dose level of Pazopanib that they are receiving may need to be adjusted, with increased monitoring.

  3 months

Study Arms (1)

Carboplatin AUC5 + escalating pazopanib

EXPERIMENTAL

Carboplatin AUC5 IV Day 1 Pazopanib in escalating dosages, 200 mg to 800 mg starting on days 2 or 3 and ending on days 19 or 21

Drug: Carboplatin; Drug: Pazopanib

Interventions

Carboplatin DRUG

Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.

Also known as: Paraplatin®, Paraplatin NovaPlus®

Carboplatin AUC5 + escalating pazopanib

Pazopanib DRUG

Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.

Also known as: Votrient

Carboplatin AUC5 + escalating pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically confirmed advanced solid tumor type that is FDA approved for treatment with Carboplatin.
• Life expectancy at least 12 wks
• ECOG performance status of 0-2
• Provide written informed
• Adequate organ system function
• FEMALES:
• Non-childbearing potential, who has had:
• A hysterectomy
• A bilateral oophorectomy (ovariectomy)
• A bilateral tubal ligation
• Is post-menopausal
• Complete abstinence from sexual intercourse 14 days before, during and at least 21 days after the last dose of investigational product
• Oral contraceptive
• Injectable progestogen

You may not qualify if:

• History or clinical evidence of central nervous system (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 6 months prior to first dose of study drug.
• Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases.
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or
• other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel.
• Presence of uncontrolled infection
• Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Links

• UNM Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Carboplatin; pazopanib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Montasur Shaheen, MD

  New Mexico Cancer Care Alliance/UNMCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: March 1, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

US (1)