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A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

Information source: New Mexico Cancer Care Alliance
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer, Metastatic

Intervention: Carboplatin (Drug); Pazopanib (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: New Mexico Cancer Care Alliance

Official(s) and/or principal investigator(s):
Montasur Shaheen, MD, Principal Investigator, Affiliation: New Mexico Cancer Care Alliance/UNMCC

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.

Clinical Details

Official title: A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose of Pazopanib when used in combination with Carboplatin

Detailed description: Pazopanib has shown a promising anti-cancer activity as a single agent tyrosine kinase inhibitor. Activity against multiple tumors such as renal cell carcinoma (RCC) and neuroendocrine tumors have been documented, and it recently gained FDA approval for the treatment of metastatic kidney cancer. Also, an impressive activity as a single agent was recently reported in non-small cell lung cancer (NSCLC) in the neoadjuvant setting, where tumor shrinkage occurred in 86% of patients. Encouraging activity has also been seen in cervical cancer, ovarian cancer and soft tissue sarcomas. Multi-kinase targeting is an approach that may prove beneficial in a number of patient populations. In particular cancers such as breast, colon, pancreas etc., patients represent heterogeneous population of small groups based on genetic analyses. Some of these populations may benefit when multiple agents are given which have similar, but distinct targets of action. Dosages and therefore associated toxicities might be reduced by such an approach.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 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

- Implants of levonorgestrel

- Estrogenic vaginal ring

- Percutaneous contraceptive patches

- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate

of less than 1% per year

- Sole male partner sterilization prior to the female subject's entry - Double barrier

method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/ gel/ film/cream/suppository)

- If lactating: discontinue nursing prior to the first dose, during and for 14 days

following the last dose of study drug Exclusion Criteria:

- 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

- Myocardial infarction

- Unstable angina

- Coronary artery bypass graft surgery

- Symptomatic peripheral vascular disease

- Class III or IV congestive heart failure, as defined by the New York Heart

Association (NYHA)

- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater

than or equal to 140 mmHg or diastolic blood pressure (DBP) of greater than or equal to 90mmHg] Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.

- History of cerebrovascular accident including transient ischemic attack (TIA),

pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible

- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or

presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)

- Evidence of active bleeding or bleeding diathesis

- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

- Hemoptysis within 8 weeks of first dose of study drug

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition

that could interfere with subject's safety, provision of informed consent, or compliance with study procedures

- Treatment with any of the following anti-cancer therapies:

- Radiation therapy, surgery or tumor embolization within 14 days prior to the first

dose of pazopanib OR

- Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal

therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib

- Any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1

and/or that is progressing in severity, except alopecia

Locations and Contacts

University of New Mexico Cancer Center, Albuquerque, New Mexico 87131-0001, United States
Additional Information

UNM Cancer Center

New Mexico Cancer Care Alliance

Starting date: August 2012
Last updated: June 17, 2015

Page last updated: August 23, 2015

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