Know Cancer

or
forgot password

Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma


Phase 1b

- To determine the dose of vorinostat that can be safely combined with gemcitabine and
docetaxel in patients with advanced sarcomas.

- To characterize the Pharmacokinetics (PK) and Pharmacodynamics (PD) of vorinostat when
combined with gemcitabine and docetaxel in patients with advanced sarcomas.

Phase 2

- To determine the safety and efficacy of gemcitabine and docetaxel in combination with
vorinostat in patients with advanced sarcomas. The hypothesis is that gemcitabine and
docetaxel + vorinostat will be safe and will improve the 6-months progression-free
rates (PFR) of the combination by 20% (from 20% to 40%).

- To determine the objective response rate, progression-free, and overall survival of
patients with advanced sarcomas treated with gemcitabine and docetaxel + vorinostat;

- To develop a predictive molecular signature of response to treatment in advanced
sarcomas.


Inclusion Criteria:



- Patients must have histologically confirmed soft tissue sarcoma with evidence of
metastatic or unresectable disease.

- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors
1.1.

- Up to 2 prior cytotoxic treatment regimens in the metastatic setting are allowed.
Adjuvant treatment will not be considered a prior line of treatment.

- Age ≥18 years.

- performance status ≤2

- Life expectancy of greater than 12 weeks.

- Patients must have normal organ and marrow function

- Peripheral neuropathy, if present, should be ≤ grade 1.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- The following specific histologic subtypes of soft tissue sarcomas will be excluded:
GIST, Kaposi's sarcoma, mesothelioma, dermatofibrosarcoma, chordoma, alveolar
soft-part sarcoma. Also, all bone sarcomas are excluded including Ewing's sarcoma,
osteosarcoma, GIST, low grade chondrosarcoma, and chordoma.

- Patients who have had treatment with chemotherapy or radiotherapy within 4 weeks (6
weeks for nitrosoureas or mitomycin C) prior to starting study treatment or those who
have not recovered from adverse events due to agents administered more than 4 weeks
earlier.

- Patients who are receiving any other investigational agents.

- Patients with known brain metastases should be excluded

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemcitabine, docetaxel, vorinostat.

- Patients who have received the combination of gemcitabine and docetaxel in the
metastatic setting are excluded.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant and breastfeeding women are excluded from this study.

- Patients taking concomitant histone deacetylase (HDAC) inhibitors. Use of inhibitor
like compounds such as valproic acid for epilepsy is permitted if there is at least a
2 week wash out.

- HIV-positive patients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

For phase 1 portion: To determine the safety, tolerability, and Phase 2 recommended dose (RP2D) of the combination.

Outcome Description:

To determine the dose of vorinostat that can be safely combined with gemcitabine and docetaxel in patients with advanced sarcomas

Outcome Time Frame:

5 years or until disease progression/survival

Safety Issue:

Yes

Principal Investigator

Hussein Tawbi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

UPCI# 12-104

NCT ID:

NCT01879085

Start Date:

June 2013

Completion Date:

December 2020

Related Keywords:

  • Sarcoma
  • advanced
  • metastatic
  • unresectable
  • soft
  • tissue
  • sarcomas
  • Sarcoma

Name

Location

Hillman Cancer Center Pittsburg, Pennsylvania  15232