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Platinum-based Chemotherapy

Chemotherapy for Oropharyngeal Cancer (OPTIMA Trial)

Phase 2
Waitlist Available
Led By Everett Vokes, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The primary and nodal involvement must have been defined bi- or uni-dimensional measurements measurable by RECIST
For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based testing) is required for enrollment and treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

OPTIMA Trial Summary

This trial is studying a combination of drugs, including nab-paclitaxel and carboplatin, given before chemoradiation, followed by response-based local therapy, as a treatment for HPV-related oropharyngeal cancer.

Who is the study for?
This trial is for patients with stage III or IV HPV-related oropharyngeal cancer. They must have confirmed HPV-positive squamous cell carcinoma, no prior head and neck cancer treatments, good physical health (ECOG 0-1), adequate organ function, and not be pregnant. Patients with certain other cancers within the last 3 years or serious medical conditions are excluded.Check my eligibility
What is being tested?
The study tests nab-paclitaxel and carboplatin chemotherapy followed by tailored local therapy based on response in treating advanced HPV-related throat cancer. The goal is to shrink tumors before chemoradiation to potentially reduce treatment doses and side effects.See study design
What are the potential side effects?
Chemotherapy drugs like nab-paclitaxel and carboplatin can cause side effects including nerve damage, fatigue, blood count changes, digestive issues, allergic reactions, and increased risk of infection. Radiation may lead to skin irritation at the treated site.

OPTIMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer's size and spread can be measured using standard imaging.
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My tumor has been tested for HPV accurately.
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My cancer is at an advanced stage according to the AJCC guidelines.
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My cancer's primary and nodal involvement can be checked by physical exam.
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I am fully active or able to carry out light work.
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My HPV status was checked with a specific test.
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My throat cancer is p16 positive, as confirmed by a specific test.
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I have not had radiation or chemotherapy for head or neck cancer.
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My cancer is HPV-positive squamous cell carcinoma.
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I am willing and able to sign the consent form for this study.
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My kidney function is normal, based on recent tests.
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My kidney function, measured by creatinine clearance, fits the trial's requirements.
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I haven't had surgery for head or neck cancer in the last 8 weeks, except for a lymph node biopsy.

OPTIMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1
Secondary outcome measures
Cancer-specific Survival
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only
Overall Survival
+3 more
Other outcome measures
Changes in Reactive T Cells
Histologic Appearance of Post-CRT Tumor Tissue
Histologic Appearance of Post-induction Tumor Tissue

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093
59%
Nausea
59%
Diarrhoea
48%
Neutropenia
40%
Fatigue
32%
Vomiting
29%
Alopecia
27%
Constipation
25%
Decreased appetite
25%
Anaemia
24%
Abdominal pain
23%
Rash
21%
Headache
19%
Epistaxis
15%
Arthralgia
15%
Drug hypersensitivity
15%
Thrombocytopenia
15%
Neuropathy peripheral
13%
Dysgeusia
13%
Stomatitis
12%
Dizziness
12%
Dyspepsia
12%
Leukopenia
12%
Asthenia
11%
Dyspnoea
11%
Nail disorder
11%
Peripheral sensory neuropathy
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Hemorrhoids
8%
Insomnia
8%
Back pain
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Nasopharyngitis
7%
Cough
7%
Bone pain
7%
Erythema
7%
Flushing
7%
Myalgia
7%
Abdominal pain upper
7%
Pyrexia
7%
Chest pain
7%
Musculoskeletal pain
5%
Lethargy
5%
Dry skin
5%
Paraesthesia
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Abdominal distension
1%
Ascites
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Gastrointestinal haemorrhage
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy + Pertuzumab
Chemotherapy

OPTIMA Trial Design

3Treatment groups
Experimental Treatment
Group I: Group C (combination chemotherapy, high-dose radiation)Experimental Treatment9 Interventions
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.* *NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.
Group II: Group B (combination chemotherapy, low-dose radiation therapy)Experimental Treatment8 Interventions
Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Group III: Group A (radiation therapy alone)Experimental Treatment5 Interventions
Patients undergo radiation therapy once daily for weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
paclitaxel albumin-stabilized nanoparticle formulation
2008
Completed Phase 2
~960
carboplatin
2010
Completed Phase 3
~4790
radiation therapy
1994
Completed Phase 3
~13390
paclitaxel
1996
Completed Phase 3
~4310
fluorouracil
1994
Completed Phase 3
~8440
hydroxyurea
2005
Completed Phase 4
~660
cisplatin
1997
Completed Phase 3
~3290
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
995 Previous Clinical Trials
816,606 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,584 Total Patients Enrolled
Everett Vokes, MDPrincipal InvestigatorUniversity of Chicago
7 Previous Clinical Trials
289 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025