Phase 2 N=27 Treatment

Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Thymoma · Thymic Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT00198133 ↗

Enrolled (actual)

Serious AEs

18.5%

Results posted

Jan 2016

Primary outcome: Primary: Objective Response Rate (Complete and Partial Response) — 26.7; 9.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Premetrexed (Alimta) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Patrick Joseph Loehrer Sr.
Primary completion: Dec 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (Complete and Partial Response)	26.7; 9.1	—
SECONDARY Duration of Remission	4.0; 3.8	—
SECONDARY Grade 3/4 Treatment Related Adverse Events	1; 1	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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 /=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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00198133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.