Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

Summary

This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.

Conditions

• Solid Neoplasm
• Stage III Pancreatic Cancer
• Stage IIIA Breast Cancer
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Breast Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Stage IV Non-Small Cell Lung Cancer
• Stage IVA Pancreatic Cancer
• Stage IVB Pancreatic Cancer
• Sarcoma
• Colorectal Cancer
• Head and Neck Cancer
• Cancer of Unknown Primary
• Bladder Cancer
• Ovarian Cancer

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Palbociclib

Given PO

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Olatunji B Alese, MD · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-24

Primary Completion

2021-10-15

Completion

2021-10-15

Countries

• United States

Study Locations