NCT00198133

Brief Summary

To study the efficacy of Alimta as a single agent in thymic cancers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 25, 2016

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Results QC Date

December 16, 2015

Last Update Submit

July 8, 2019

Conditions

ThymomaThymic Carcinoma

Keywords

ThymomaThymic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (Complete and Partial Response)

    The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.

    Up to 3 years

Secondary Outcomes (2)

  • Duration of Remission

    Time from the date of remission until progression or death, assessed up to 3 years

  • Grade 3/4 Treatment Related Adverse Events

    Up to 3 years

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Pemetrexed infusion once every 21 days (one cycle).

Drug: Premetrexed (Alimta)

Interventions

Premetrexed (Alimta)DRUG

Pemetrexed will be 500 mg/m2 IV every 3 weeks

Pemetrexed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
  • Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
  • Patients may have had prior chemotherapy for metastatic disease
  • Adequate organ function as defined by: bili \</=1.5; calc. crt clr of \>/=45; hematologic-granulocytes \>/=1500 \& plt \>/=100K.
  • Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
  • ECOG performance status of 0 or 1

You may not qualify if:

  • Acute intercurrent infection or complications
  • pregnancy or lactating patients
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
  • Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Gbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16.

    PMID: 30121390BACKGROUND

MeSH Terms

Conditions

Thymoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Results Point of Contact

Title
Patrick J. Loehrer, Sr., M.D.
Organization
IndianaU
ploehrer@iu.edu
(317)944-0920

Study Officials

  • Patrick Loehrer, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

May 1, 2012

Last Updated

July 22, 2019

Results First Posted

January 25, 2016

Record last verified: 2019-07

Locations

US(1)