NCT00890955

Brief Summary

Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful. This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
1 country

10 active sites

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

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

April 29, 2009

Last Update Submit

December 21, 2015

Conditions

Lung Cancer

Keywords

Solid tumors

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.

    24 months

Secondary Outcomes (2)

  • To determine the toxicities of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.

    24 months

  • To assess response to the combination of amrubicin and cyclophosphamide

    24 months

Study Arms (1)

1

EXPERIMENTAL

Amrubicin + Cyclophosphamide 3+3 design with the following dose levels: Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2 Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2 Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2 Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2 Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2

Drug: AmrubicinDrug: Cyclophosphamide

Interventions

AmrubicinDRUG

* Dose Level -1: 20mg/m2 * Dose Level 1: 25mg/m2 * Dose Level 2: 30mg/m2 * Dose Level 3: 35mg/m2 * Dose Level 4: 40mg/m2 Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.

1
CyclophosphamideDRUG

Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).

1

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.
  • Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.
  • Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.
  • Prior radiation therapy is allowed to \< 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.
  • Must be willing to consent to the blood sample collection for SNP analysis.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 30 days following completion of protocol therapy.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age \> 18 years.

You may not qualify if:

  • No prior therapy with cyclophosphamide or anthracyclines.
  • No treatment with any investigational agent within 28 days prior to registration for protocol therapy.
  • No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
  • No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
  • No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center Extramural Research Program

Rockledge, Pennsylvania, 19046, United States

Location

Related Publications (1)

  • Jalal SI, Hanna N, Zon R, Masters GA, Borghaei H, Koneru K, Badve S, Prasad N, Somaiah N, Wu J, Yu Z, Einhorn L. Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies: HOG LUN 07-130. Am J Clin Oncol. 2017 Aug;40(4):329-335. doi: 10.1097/COC.0000000000000160.

    PMID: 25503432RESULT

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

amrubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Lawrence Einhorn, M.D.

    Hoosier Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

April 29, 2009

First Posted

April 30, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(10)