NCT01178112

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of trientine and carboplatin that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

August 1, 2014

Enrollment Period

4.1 years

First QC Date

August 6, 2010

Last Update Submit

November 16, 2015

Conditions

Advanced Cancers

Keywords

MetastasisCarboplatinTrientineChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Carboplatin with Trientine

    MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks). DLT defined as treatment-related grade 3 or greater nonhematological toxicity other than nausea, vomiting, or fatigue.

    4 weeks

Secondary Outcomes (1)

  • Treatment Response of Maximum Tolerated Dose (MTD) of Carboplatin with Trientine

    After 2, 28 day cycles

Study Arms (4)

Trientine + Carboplatin MTD Group

EXPERIMENTAL

Trientine starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group.

Drug: TrientineDrug: Carboplatin

MTD Expansion Group

EXPERIMENTAL

Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group

Drug: Trientine MTDDrug: Carboplatin MTD

Carboplatin PK Expansion Group

EXPERIMENTAL

Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours.

Drug: Trientine MTDDrug: Carboplatin MTDOther: PK Testing

Trientine PK Expansion Group

EXPERIMENTAL

Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours.

Drug: Trientine MTDDrug: Carboplatin MTDOther: PK Testing

Interventions

TrientineDRUG

Starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days.

Trientine + Carboplatin MTD Group
CarboplatinDRUG

Starting dose area under curve (AUC) 4 by vein over two hours on day 1, and once every 28 days.

Also known as: Paraplatin
Trientine + Carboplatin MTD Group
Trientine MTDDRUG

Maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2.

Carboplatin PK Expansion GroupMTD Expansion GroupTrientine PK Expansion Group
Carboplatin MTDDRUG

Maximum tolerated dose found in MTD Dose Escalation Group

Also known as: Paraplatin
Carboplatin PK Expansion GroupMTD Expansion GroupTrientine PK Expansion Group
PK TestingOTHER

Blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours.

Carboplatin PK Expansion GroupTrientine PK Expansion Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must have an advanced malignancy that has either failed one or more prior therapies, or for whom there is no established standard of care therapy that prolongs survival by at least 3 months.
  • Only in 1 of 3 expansion cohorts, we will plan to enroll 14 subjects with platinum-resistant malignancy. Patient with platinum-resistant malignancy is defined to have had a treatment-free interval of less than 6 months following a platinum-based regimen.
  • Patient of any age and any gender. However, those who are 12 years old or younger will be eligible after consultation with their pediatric physicians regarding dose initiation and modification of trientine.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patient is willing to comply with study procedures and follow-up examinations.
  • Patient or primary care taker must be informed of the investigational nature of this study and must sign and give written Institutional Review Board (IRB)-approved informed consent in accordance with institutional guidelines.
  • If patient is of childbearing potential, she or he must agree to practice an effective method of birth control prior to study entry, for the duration of study participation, and for 30 days after the last study dose.
  • Patient has adequate organ functions: serum bilirubin \</= 2.0 mg/dL; ALT \</= 3 x upper limit of normal (ULN), or ALT \</= 5 x ULN if the patient has hepatic metastasis; serum creatinine \</= 1.5 mg/dL or a calculated creatinine clearance of at least 60 mL/min.
  • Patient has adequate bone marrow reserve: absolute neutrophil count (ANC) \>/= 1,500 /ul, Platelet count \>/= 100,000 /ul , and Hemoglobin \>/= 9.0 g/dL.

You may not qualify if:

  • Patient receiving any concurrent chemotherapy.
  • Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active, uncontrolled, serious infection and cardiac dysfunction.
  • Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
  • Known anaphylactic or severe hypersensitivity to study drugs or their analogs.
  • Patient has failed to recover from any prior surgery within 4 weeks of study entry.
  • Patient is pregnant or lactating.
  • Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents), or failure to recover from the toxic effect of any of these therapies prior to study entry.
  • Patient has any signs of intestinal obstruction interfering with nutrition.
  • Patient has a known history of central nervous system (CNS) metastasis unless the patient has had treatment with surgery or radiation therapy, and is neurologically stable.
  • Patient is not able to swallow oral medication.
  • Patient has clinical evidence of copper deficiency (i.e. ceruloplasmin level was less than 15 mg/dL or free serum copper level less than 2.2 ug/dL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Fu S, Naing A, Fu C, Kuo MT, Kurzrock R. Overcoming platinum resistance through the use of a copper-lowering agent. Mol Cancer Ther. 2012 Jun;11(6):1221-5. doi: 10.1158/1535-7163.MCT-11-0864. Epub 2012 Apr 5.

    PMID: 22491798DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

TrientineCarboplatin

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsCoordination Complexes

Study Officials

  • Siqing Fu, MD, PHD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 9, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 18, 2015

Record last verified: 2014-08

Locations

US(1)