Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 19, 2021
  • participants needed
    90
  • sponsor
    Emory University
Updated on 19 February 2021
ct scan
cancer
measurable disease
tumor growth
lung cancer
MRI
metastasis
neutrophil count
carboplatin
liver metastasis
tumor cells
solid tumors
cancer chemotherapy
spiral computed tomography
solid tumour
palbociclib
squamous non-small cell lung cancer

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.

Description

PRIMARY OBJECTIVES:

I. Assess the safety and tolerability of palbociclib when administered along with cisplatin or carboplatin.

II. Establish the recommended phase 2 dose (RP2D) of the tested combinations.

SECONDARY OBJECTIVES:

I. Characterize the pharmacokinetic (PK) profiles of cisplatin, carboplatin.

II. Obtain preliminary evidence of anti-tumor efficacy of the tested combination regimens.

III. Conduct PK/pharmacodynamics (PD) correlative analyses using palbociclib trough concentration and cyclin-dependent kinase 4 (CDK4) inhibition read-outs in tumor and surrogate samples collected on course 1 day 22 (C1D22).

IV. Assess potential association between tissue-based biomarkers and efficacy.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms.

ARM A: Patients receive cisplatin intravenously (IV) over 30-60 minutes on day 1 and palbociclib orally (PO) once daily (QD) on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 4 weeks.

Details
Condition urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Rectal disorder, bladder cancer, bladder disorder, Ovarian Cancer, Sarcoma, head and neck cancer, All Solid Tumors, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Ovarian Function, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Metastatic Breast Cancer, Solid Neoplasm, Stage IV Breast Cancer, Stage III Pancreatic Cancer, Urothelial Cancer, Stage IVA Pancreatic Cancer, Stage IVB Pancreatic Cancer, Recurrent Ovarian Cancer, Solid Tumour, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Cancer of Unknown Primary, Sarcoma (Pediatric), Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Bladder Disorders, Soft Tissue Sarcoma, Bladder Carcinoma, Urologic Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, colorectal neoplasm, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, carcinoma of the bladder, sarcomas, soft tissue sarcomas, colorectal cancers, cancer of the head and neck, ovarian tumors, cancer, colorectal, colorectal tumor, tumors, colorectal, bladder tumor, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Palbociclib
Clinical Study IdentifierNCT02897375
SponsorEmory University
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Stage IIIB Breast Cancer or bladder disorder or Stage III Pancreatic Cancer or Ovarian Cancer or head and neck cancer or Stage II...?
Do you have any of these conditions: Ovarian disorder or Metastatic Breast Cancer or Solid Tumors or Recurrent Ovarian Cancer or Stage IIIC Breast Cancer or Urologic Cancer or bladder dis...?
Do you have any of these conditions: Solid Tumors or colorectal cancers or sarcomas or Urologic Cancer or Sarcoma or All Solid Tumors or Stage IIIB Breast Cancer or Ovarian disorder or St...?
Do you have any of these conditions: Colon Cancer Screening or cancer of the ovary or Soft Tissue Sarcoma or Ovarian disorder or Solid Tumors or cancer, colorectal or Ovarian Function or ...?
Patients must have histologically or cytologically confirmed solid organ malignancy
Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
Eastern Cooperative Oncology Group (ECOG) performance status 2
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as 20 mm ( 2 cm) with conventional techniques or as 10 mm ( 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Leukocytes 3,000/mL
Absolute neutrophil count 1,500/mL
Platelets 100,000/mL
Hemoglobin 10 g/dL
Total bilirubin 1.5 institutional upper limit of normal (except for patients with Gilbert disease)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) 2.5 institutional upper limit of normal (up to 5 X upper limit of normal [ULN] for patients with liver metastasis)
Creatinine within normal institutional limits OR creatinine clearance 60 mL/min/1.73 m for patients with creatinine levels above institutional normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48 hours) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
Oral targeted therapy within five days or five half-lives, whichever is longer, prior to initiating protocol therapy treatment
Patients who are receiving any other investigational agents
Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
Patients with symptomatic uncontrolled brain metastases are excluded; (patients with stable treated or asymptomatic untreated brain metastasis not requiring glucocorticoids are allowed)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, carboplatin or cisplatin
Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window
Uncontrolled intercurrent illness including, but not limited to
Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation
Symptomatic congestive heart failure (requiring hospital stay within the last 6 months)
Myocardial infarction within the last 6 months
Unstable angina pectoris, cardiac arrhythmia
Psychiatric illness
Social situations or circumstances that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with palbociclib
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
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