NCT00843635

Brief Summary

RATIONALE: Biological therapies, such as tadalafil, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating patients who are undergoing surgery for cancer of the oral cavity or oropharynx.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable head-and-neck-cancer

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

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 13, 2015

Completed
Last Updated

October 19, 2015

Status Verified

September 1, 2015

Enrollment Period

6.6 years

First QC Date

February 12, 2009

Results QC Date

June 3, 2015

Last Update Submit

September 25, 2015

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the lip and oral cavitystage I verrucous carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavity

Outcome Measures

Primary Outcomes (3)

  • Ratio of MDSC Concentration in the Blood

    Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.

    Baseline, End of Treatment at time of Surgery

  • Ratio of T-reg Cell Concentration in the Blood

    Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..

    Baseline, End of Treatment at Time of Surgery

  • Ratio of Tumor-specific T-cell Concentration in the Blood

    Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.

    Baseline, End of Treatment at Time of Surgery

Secondary Outcomes (2)

  • Optimal Dosing Schedule for Tadalafil

    Baseline, End of Treatment at Time of Surgery.

  • Number of Participants Experiencing Adverse Events

    From Day 1 to Day 20

Study Arms (3)

Arm A - Tadalafil 10mg

EXPERIMENTAL

Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Drug: Tadalafil

Arm B - Tadalafil 20mg

EXPERIMENTAL

Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Drug: Tadalafil

Arm C - Placebo

PLACEBO COMPARATOR

Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.

Other: Placebo

Interventions

TadalafilDRUG

Given orally

Also known as: Cialis
Arm A - Tadalafil 10mgArm B - Tadalafil 20mg
PlaceboOTHER

Given orally

Arm C - Placebo

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with surgically resectable oral cavity SCC, all subsites, T1 - T4, N0 - N3
  • Patients with surgically resectable oropharyngeal SCC, all subsites, T1 - T2, N0 - N1
  • Patients with surgically resectable T4 oropharyngeal SCC, all subsites, N0 - N3
  • Patients must be 18 years old or older

You may not qualify if:

  • Patients with previous surgical resection, radiation, or chemotherapy will be excluded to rule out possible effects of local tissue changes secondary to previous treatment
  • Patients with surgically unresectable disease at primary site or regional lymph nodes
  • Patients with T1 - T2 SCC oropharynx, N2 - N3
  • Patients with T3 SCC oropharynx , N0 - N3
  • Any patient for whom non-surgical therapy is recommended as treatment of choice after multidisciplinary treatment evaluation
  • Patients with an altered mental status or not capacitated for their medical decision making
  • Patients with severe or unstable cardiac or cerebrovascular disease are excluded
  • myocardial infarction within the last 90 days
  • unstable angina or angina occurring during sexual intercourse
  • New York Heart Association Class 2 or greater heart failure in the last 6 months
  • uncontrolled arrhythmias
  • hypotension (\<90/50 mm Hg), or uncontrolled hypertension (\>170/100 mm Hg)
  • stroke within the last 6 months
  • Left ventricle outflow obstruction.
  • Pregnant and nursing mothers will not be enrolled given unknown effects to offspring
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Weed DT, Vella JL, Reis IM, De la Fuente AC, Gomez C, Sargi Z, Nazarian R, Califano J, Borrello I, Serafini P. Tadalafil reduces myeloid-derived suppressor cells and regulatory T cells and promotes tumor immunity in patients with head and neck squamous cell carcinoma. Clin Cancer Res. 2015 Jan 1;21(1):39-48. doi: 10.1158/1078-0432.CCR-14-1711. Epub 2014 Oct 15.

    PMID: 25320361RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Limitations and Caveats

Race/Ethnicity baseline characteristics reported for 34 of 35 patients enrolled. Data analyzed for outcome measure for the 31 participants who completed the study.

Results Point of Contact

Title
Donald T. Weed MD FACS
Organization
University of Miami
dweed@miami.edu
305-243-9095

Study Officials

  • Donald T. Weed, MD

    University of Miami Sylvester Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

September 1, 2008

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 19, 2015

Results First Posted

August 13, 2015

Record last verified: 2015-09

Locations

US(1)