Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)

NCT00511485 | Completed Phase 2

• 2 other identifiers: 8109-008EC-FV-03
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with progressive adenocarcinoma of the lung.

Conditions

Adenocarcinoma of the Lung

Keywords

Cancer; Adenocarcinoma; Phase II; Lung; Non-small cell lung cancer; NSCLC; EC145; EC20

Outcome Measures

Primary Outcomes (1)

• Percentage of patients deriving clinical benefit

  Clinical benefit is defined as the ability to receive 4 or more cycles (i.e., months) of therapy without progression of disease.

Secondary Outcomes (2)

• Tumor responses to EC145 therapy

  Duration of EC145 therapy will vary according to individual participant response.

• Progression-free survival, response duration, and overall survival time observed after EC145 therapy

  2 years after completing therapy with EC145 and the 30-day follow-up period.

Study Arms (1)

Etarfolatide + Vintafolide

EXPERIMENTAL

Screening: After completion of all screening procedures and confirmation of eligibility, all participants receive a 1- to 2-mL injection of 0.1 mg etarfolatide labeled with 20 to 25 mCi of technetium-99m. Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) computed tomography (CT), participant may proceed into maintenance phase. Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Participants continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined clinical benefit.

Drug: Vintafolide; Drug: Etarfolatide

Interventions

Vintafolide DRUG

Induction: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: vintafolide 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

Etarfolatide + Vintafolide

Etarfolatide DRUG

Etarfolatide + Vintafolide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced, progressive, adenocarcinoma of the lung.
• Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can include an epidermal growth factor receptor \[EGFR\] inhibitor). There is no upper limit to the number of prior chemotherapeutic regimens.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• At least 4 weeks from prior therapy and recovered from associated acute toxicities.
• Radiographic evidence of measurable disease and ertafolide "positive" tumor.
• Adequate bone marrow reserve, hepatic, and renal function.
• Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods.

You may not qualify if:

• Serious comorbidities (as determined by the Principal Investigator).
• History of carcinomatous peritonitis.
• History of severe bowel obstruction (as determined by the Principal Investigator).
• Women who are pregnant or lactating.
• Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site.
• Participants requiring palliative radiotherapy at time of study entry.
• Note: Participants with central nervous system (CNS) metastasis are eligible if a) they have been treated for the CNS metastasis and have been clinically stable (with regard to their CNS disease) for \>4 weeks and b) they do not require steroids or antiseizure medications (i.e., for seizure control), or if the CNS metastasis has been untreated to date, it is not associated with a midline shift or significant edema and there is no clinically-evident requirement for steroids or antiseizure medication. In either situation, participants must be off steroids and/or antiseizure medications for at least 14 days.

Sponsors & Collaborators

• Endocyte: lead

Related Publications (1)

• Reddy JA, Dorton R, Westrick E, Dawson A, Smith T, Xu LC, Vetzel M, Kleindl P, Vlahov IR, Leamon CP. Preclinical evaluation of EC145, a folate-vinca alkaloid conjugate. Cancer Res. 2007 May 1;67(9):4434-42. doi: 10.1158/0008-5472.CAN-07-0033.

  PMID: 17483358 BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma of Lung; Neoplasms; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

EC145; technetium 99m etarfolatide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Binh Nguyen, MD, PhD

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 6, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 27, 2015

Record last verified: 2015-02