A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2018 |
Start Date: | October 12, 2015 |
End Date: | August 2019 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + IMRT for Locally Advanced Non-Metastatic SCC of the Oral Cavity/Oropharynx
The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered
prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and
severity of radiation induced oral mucositis in patients who have been diagnosed with locally
advanced, non-metastatic squamous cell carcinoma of the head and neck.
prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and
severity of radiation induced oral mucositis in patients who have been diagnosed with locally
advanced, non-metastatic squamous cell carcinoma of the head and neck.
GT-201 is a randomized, double-blind, placebo-controlled, multi-center study conducted in the
U.S. to evaluate GC4419 administered IV for the reduction of incidence, duration, and
severity of radiation induced oral mucositis in patients receiving cisplatin plus
intensity-modulated radiation therapy for post-operative, or definitive treatment of locally
advanced, non-metastatic squamous cell carcinoma of the head and neck, limited to the oral
cavity or oropharynx. Patients will be randomized equally to 1 of 3 treatment arms:
Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa,
floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.
All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until
the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral
mucositis resolves to ≤ Grade 1.
Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and
complete requirements for primary endpoint analysis, which is defined as patients receiving a
minimum cumulative dose of 60 Gy.
U.S. to evaluate GC4419 administered IV for the reduction of incidence, duration, and
severity of radiation induced oral mucositis in patients receiving cisplatin plus
intensity-modulated radiation therapy for post-operative, or definitive treatment of locally
advanced, non-metastatic squamous cell carcinoma of the head and neck, limited to the oral
cavity or oropharynx. Patients will be randomized equally to 1 of 3 treatment arms:
Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT),
concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over
approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for
3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa,
floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.
All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until
the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral
mucositis resolves to ≤ Grade 1.
Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and
complete requirements for primary endpoint analysis, which is defined as patients receiving a
minimum cumulative dose of 60 Gy.
Inclusion Criteria:
1. Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck,
defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin
plus concurrent IMRT Note: Patients with unknown primary tumors whose treatment plan
matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible
for the trial.
2. Treatment plan to receive a continuous course of IMRT delivered as single daily
fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy.
Planned radiation treatment fields must include at least two oral sites (buccal
mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total
of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully
recovered from surgery, and patients who may have surgery in the future are eligible.
3. Treatment plan to receive standard cisplatin monotherapy administered either every
three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The
decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will
be at the discretion of the investigator.
4. Age 18 years or older
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
6. Adequate hematologic function as indicated by:
- Absolute neutrophil counts (ANC) ≥ 1,500/mm3
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm3
7. Adequate renal and liver function as indicated by:
- Serum creatinine acceptable for treatment with cisplatin per institutional
guidelines
- Total bilirubin ≤ 1.5 x upper-normal limit (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
8. Human papilloma virus (HPV) status in tumor has been documented using tumor
immunohistochemistry for HPV-p16 or other accepted test
9. Serum pregnancy test negative for females of childbearing potential
10. Males and females must agree to use effective contraception starting prior to the
first day of treatment and continuing for 30 days after the last dose of GC4419
11. Properly obtained written informed consent
Exclusion Criteria:
1. Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
2. Metastatic disease (Stage IV C)
3. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites or
more than 25% of total body marrow-bearing area (potentially interfering with
chemotolerance)
4. Prior induction chemotherapy
5. Receiving any approved or investigational anti-cancer agent other than those provided
for in this study
6. Participation in another clinical trial or use of another investigational agent within
30 days of study entry
7. Requirement for significantly modified diet (liquids and/or solids) due to compromised
oral/pharyngeal function at baseline
8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition
for any reason
9. Malignant tumors other than HNC within the last 5 years, unless treated definitively
and with low risk of recurrence in the judgment of the treating investigator
10. Active infectious disease excluding oral candidiasis
11. Presence of oral mucositis (WHO Score ≥ Grade 1) at study entry
12. Known history of HIV or active hepatitis B/C (patients who have been vaccinated for
hepatitis B and do not have a history of infection are eligible)
13. Female patients who are pregnant or breastfeeding
14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds
15. Requirement for concurrent treatment with nitrates or other drugs that may, in the
judgment of the treating investigator, create a risk for a precipitous decrease in
blood pressure
We found this trial at
58
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: John Holland, MD
Phone: 503-494-8756
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Ariel Birnbaum, MD
Phone: 401-444-5014
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1660 South Columbian Way
Seattle, Washington 98108
Seattle, Washington 98108
(206) 762-1010
Principal Investigator: Tony Quang, MD, JD
Phone: 206-277-3101
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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2000 E Greenville St
Anderson, South Carolina 29621
Anderson, South Carolina 29621
(864) 512-4640
Principal Investigator: Leander Cannick, MD
Phone: 864-512-4650
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Francis Worden, MD
Phone: 734-647-2148
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ashland, Kentucky 41101
Principal Investigator: Anshu Jain, MD
Phone: 606-388-2643
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Billings, Montana 59102
Principal Investigator: Patrick W Cobb, MD, FACP
Phone: 406-238-6996
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801 North 29th Street
Billings, Montana 59107
Billings, Montana 59107
406-238-2500
Principal Investigator: Pamela Smith, MD
Phone: 406-435-7483
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Burlington, Vermont 05405
Principal Investigator: Maura Barry, MD
Phone: 802-656-9446
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Charleston, South Carolina
Principal Investigator: Charles Holladay, MD
Phone: 843-576-1024
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Maria Matsangou, MD
Phone: 312-695-1356
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Columbia, Missouri 65212
Principal Investigator: Michael Trendle, MD
Phone: 573-884-0053
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Columbus, Ohio 43210
Principal Investigator: Dukagjin Blakaj, MD
Phone: 614-685-4612
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Easton, Pennsylvania 18045
Principal Investigator: Sanjiv Agarwala, MD
Phone: 484-503-4715
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Everett, Washington 98201
Principal Investigator: William Wisbeck, MD
Phone: 425-297-5531
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263 Farmington Avenue
Farmington, Connecticut 06030
Farmington, Connecticut 06030
Principal Investigator: Rajesh Lalla, BDS, PhD
Phone: 860-676-3454
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Flemington, New Jersey 08822
Principal Investigator: Waqas Rehman, MD
Phone: 908-237-2330
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Goshen, Indiana 46526
Principal Investigator: James Wheeler, MD
Phone: 574-364-2359
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Grand Junction, Colorado 81501
Principal Investigator: Vernon King, MD
Phone: 970-298-7043
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Greenville, North Carolina 27834
Principal Investigator: Sharon Gordon, DDS MPH PHD
Phone: 252-737-7079
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Holiday, Florida 34691
Principal Investigator: Roberto A Araujo, MD
Phone: 727-849-8036
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Iowa City, Iowa 52242
Principal Investigator: Carryn Anderson, MD
Phone: 319-384-7912
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205 North East Avenue
Jackson, Michigan 49201
Jackson, Michigan 49201
Principal Investigator: Ganesh Kudva, MD
Phone: 517-205-1522
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Johnson City, Tennessee 37604
Principal Investigator: Kyle Colvett, MD
Phone: 423-431-5654
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Jonesboro, Arkansas 72401
Principal Investigator: Kevin Collins, MD
Phone: 870-936-7066
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Christopher Lominska, MD
Phone: 913-588-0980
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37920
Principal Investigator: Joseph Kelley, MD
Phone: 865-305-5483
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Lakeland, Florida 33805
Principal Investigator: Madhavi Venigalla, MD
Phone: 863-904-1877
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Lexington, Kentucky 40536
Principal Investigator: Mahesh Kudrimoti, MD
Phone: 859-323-0532
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Little Rock, Arkansas 72205
Principal Investigator: Omar Atiq, MD
Phone: 501-686-8274
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Long Beach, California 90822
Principal Investigator: Steve P Lee, MD, PhD
Phone: 586-826-8000
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Jorge Nieva, MD
Phone: 323-865-0514
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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601 South Floyd Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Principal Investigator: Neil Dunlap, MD
Phone: 502-333-6934
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Montebello, California 90640
Principal Investigator: John Thropay, MD
Phone: 323-724-8769
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Mohammed Almubarak, MD
Phone: 304-293-2633
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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New Orleans, Louisiana 70112
Principal Investigator: Steven J DiBiase, MD
Phone: 504-988-2987
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Orange, California 92868
Principal Investigator: Chaitali Nangia, MD
Phone: 714-456-3669
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Orlando, Florida 32806
Principal Investigator: Elizabeth Feldman, MD
Phone: 321-841-3498
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Philadelphia, Pennsylvania 19107
Principal Investigator: Voichita Bar-Ad, MD
Phone: 215-955-1964
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Phoenix, Arizona 85004
Principal Investigator: Celine Ord, MD
Phone: 602-827-2680
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Larissa Greenberg, MD
Phone: 412-359-6851
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Port Huron, Michigan 48060
Principal Investigator: Kanu Dalal, MD
Phone: 810-216-1185
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Portland, Oregon 97239
Principal Investigator: Daniel R Clayburgh, MD
Phone: 503-721-1433
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Reno, Nevada 89502
Principal Investigator: Abhinand Peddada, MD
Phone: 775-982-5050
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Shreveport, Louisiana 71101
Principal Investigator: Scott Boniol, MD
Phone: 318-681-6007
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Spartanburg, South Carolina 29303
Principal Investigator: Amarintha Curtis, MD
Phone: 864-560-1045
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Spokane, Washington 99218
Principal Investigator: Christopher Lee, MD
Phone: 509-228-1689
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Springfield, Massachusetts 01199
Principal Investigator: Wilson Mertens, MD
Phone: 413-794-4154
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Stanford, California 94305
Principal Investigator: Wendy Hara, MD
Phone: 650-721-4069
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Sudbury, Ontario
Principal Investigator: Deborah Saunders, DDM
Phone: 705-522-6237
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Temple, Texas 76508
Principal Investigator: Alan C Gowan, DO
Phone: 254-724-5939
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Toledo, Ohio 43623
Principal Investigator: Rex Mowat, MD
Phone: 419-794-7720
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Tyler, Texas 75701
Principal Investigator: Arielle Lee, MD
Phone: 903-592-6152
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Watertown, South Dakota
Principal Investigator: Bipinkumar Amin, MD
Phone: 605-882-6803
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Winston-Salem, North Carolina 27157
Principal Investigator: Mercedes Porosnicu, MD
Phone: 336-713-7748
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