Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01820091
First received: March 21, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Folotyn
Drug: Fusilev
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    The study period will begin on the first day of Folotyn treatment (Day 1). Folotyn will be administered intravenously (IV) at a dose of 190 mg/m2 on Days 1 and 15 in a 28-day treatment cycle. Twenty-four hours after the Folotyn dose, Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned. Within a given cohort, Fusilev will be administered at the same dose and schedule after each Folotyn dose for the duration of the study.


Secondary Outcome Measures:
  • Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Impact of Fusilev on the frequency of Oral Mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Impact of Fusilev on use of Analgesics for Oral Mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Impact of Fusilev on number of Folotyn doses delivered [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 - Fusilev - 20 doses

5 mg/m2 QID (6 hours apart) starting on Days 2 and 16 (24 hours after Folotyn dose) for a total of 20 doses in a 28-day cycle

Days 2 and 16: 4 doses/day

Days 3 and 17: 4 doses/day

Days 4 and 18: 2 doses/day

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate
Drug: Fusilev
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Other Name: Levoleucovorin
Experimental: Cohort 2 - Fusilev - 12 doses

5 mg/m2 BID 8 hours apart on Days 2, 3, 4, 16, 17, and 18 for a total of 12 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate
Drug: Fusilev
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Other Name: Levoleucovorin
Experimental: Cohort 3 - Fusilev - 8 doses

5 mg/m2 BID 8 hours apart on Days 2, 3, 16, and 17 for a total of 8 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate
Drug: Fusilev
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Other Name: Levoleucovorin
Experimental: Cohort 4 - Fusilev - 4 doses

5 mg/m2 BID 8 hours apart on Days 2 and 16 for a total of 4 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate
Drug: Fusilev
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Other Name: Levoleucovorin
Experimental: Cohort 5 - Fusilev - 2 doses

5 mg/m2 once on Days 2 and 16 for a total of 2 doses in a 28-day cycle

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

Drug: Folotyn
A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
Other Name: Pralatrexate
Drug: Fusilev
Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
Other Name: Levoleucovorin

Detailed Description:

This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Histologically or cytologically confirmed Stage III B/IV NSCLC
  • Adequate hematological, hepatic, and renal function
  • Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days

Exclusion Criteria:

  • Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
  • Congestive heart failure
  • Uncontrolled hypertension
  • Known human immunodeficiency virus (HIV)-positive diagnosis
  • Previous exposure to Pralatrexate
  • Pregnant or breast-feeding women
  • Major surgery within 14 days of enrollment
  • Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
  • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01820091     History of Changes
Other Study ID Numbers: SPI-FUS-12-103
Study First Received: March 21, 2013
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014