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Alkylating agent

Chemotherapy for Head and Neck Cancer (APA Trial)

Phase 2
Waitlist Available
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arms 1 and 3 - AP: Diagnosis of selected Stage III or IVa/b HNSCC. Arm 1: T2-T4 primary tumors. Arm 3: T2T1-T4 primary tumors. Patients with no nodal disease will also be eligible. Presence of disease at the oropharynx, hypopharynx, or larynx sub-sites. Presence of measurable disease defined as lesions ≥ 10 mm with CT scan. At least 18 years of age. Women of childbearing potential and men must agree to use adequate contraception. Able to understand and sign an IRB-approved informed consent document. ECOG performance status ≤ 1. Adequate bone marrow and organ function as specified.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after completion of treatment (estimated to be 15-25 weeks)
Awards & highlights

APA Trial Summary

This trial is testing the efficacy and toxicity of two different chemotherapy treatments for head and neck squamous cell carcinoma (HNSCC), with the addition of a third arm testing a novel treatment approach for a subgroup with a very favorable prognosis.

Who is the study for?
Adults with certain stages of head and neck squamous cell carcinoma (HNSCC) can join this trial. They must have good kidney function, not need oxygen therapy, and be generally healthy with no severe COPD or recent cancers except some skin cancers. Women who can have children and men must use birth control during the study.Check my eligibility
What is being tested?
The trial is testing how well patients respond to different combinations of chemotherapy drugs nab-Paclitaxel and Cisplatin, with or without radiation therapy. It's looking at effectiveness and safety in treating HNSCC, including a lower radiation dose for HPV-related cancer.See study design
What are the potential side effects?
Possible side effects include reactions to the infusion like rash or fever, nerve damage causing numbness or pain, hearing loss from Cisplatin, fatigue, nausea, low blood counts increasing infection risk, and potential harm to an unborn baby.

APA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

APA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after completion of treatment (estimated to be 15-25 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after completion of treatment (estimated to be 15-25 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Arm 3: Median Percent Weight Loss
Secondary outcome measures
Arm 1 and Arm 3: Comparison of Disease-free Survival
Upper arm
Upper arm
+19 more

Side effects data

From 2016 Phase 2 & 3 trial • 191 Patients • NCT01881230
55%
Fatigue
55%
Alopecia
43%
Nausea
42%
Diarrhoea
42%
Anaemia
40%
Neutropenia
30%
Vomiting
28%
Oedema peripheral
28%
Headache
25%
Decreased appetite
23%
Myalgia
23%
Peripheral sensory neuropathy
22%
Asthenia
22%
Arthralgia
22%
Constipation
20%
Pyrexia
20%
Cough
15%
Dysgeusia
13%
Rash
13%
Thrombocytopenia
13%
Hypokalaemia
13%
Hypertension
13%
Weight decreased
13%
Pain in extremity
13%
Insomnia
12%
Bone pain
12%
Dyspnoea
10%
Non-cardiac chest pain
10%
Upper respiratory tract infection
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Dehydration
8%
Pleural effusion
8%
Abdominal pain upper
8%
Stomatitis
8%
Pruritus
7%
Oropharyngeal pain
7%
Pneumonia
7%
Cellulitis
7%
Neurotoxicity
7%
Paraesthesia
7%
Hot flush
7%
Fall
7%
Chills
7%
Folliculitis
7%
Leukopenia
7%
Hyperglycaemia
7%
Neuropathy peripheral
7%
Depression
7%
Erythema
7%
Abdominal pain
5%
Epistaxis
5%
Dry mouth
5%
Gastrooesophageal reflux disease
5%
Generalised oedema
5%
Influenza like illness
5%
Pain
5%
Sinusitis
5%
Urinary tract infection
5%
Spinal pain
5%
Anxiety
5%
Rash maculo-papular
5%
Rash pruritic
5%
Tachycardia
5%
Back pain
5%
Musculoskeletal chest pain
5%
Dizziness
5%
Rhinorrhoea
5%
Dyspepsia
5%
Drug hypersensitivity
5%
Neck pain
5%
Dry skin
5%
Vision blurred
3%
Bronchitis
3%
Hypoaesthesia
3%
Dyspnoea exertional
3%
Lymphoedema
2%
Haematemesis
2%
Haemorrhoidal haemorrhage
2%
Breast cellulitis
2%
Cardiac failure
2%
Palpitations
2%
Device related infection
2%
Metastases to meninges
2%
Respiratory tract congestion
2%
Lymphopenia
2%
Lacrimation increased
2%
Contusion
2%
Overdose
2%
Musculoskeletal pain
2%
Atrial fibrillation
2%
Sensory disturbance
2%
Influenza
2%
Hypomagnesaemia
2%
Ascites
2%
Endocarditis
2%
Respiratory failure
2%
Muscular weakness
2%
Device related sepsis
2%
Sepsis
2%
Confusional state
2%
Atelectasis
2%
Pneumothorax
2%
Pulmonary embolism
2%
Deep vein thrombosis
2%
Hepatic failure
2%
Nodular regenerative hyperplasia
2%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel + Gemcitabine
Arm B: Nab-Paclitaxel + Carboplatin
Arm C: Gemcitabine + Carboplatin

APA Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRTExperimental Treatment3 Interventions
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Group II: Arm 2: nab-Paclitaxel (A) + CRTExperimental Treatment3 Interventions
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment If CR/PR, three more weeks of nab-paclitaxel followed by CRT If <PR, move directly to CRT if not surgical candidates. CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy. It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Group III: Arm 1: nab-Paclitaxel and cisplatin (AP) + CRTExperimental Treatment3 Interventions
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) If <PR, move directly to CRT if not surgical candidates. CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Cisplatin
2013
Completed Phase 3
~1940
Cetuximab
2011
Completed Phase 3
~2480
nab-Paclitaxel
2014
Completed Phase 3
~7680

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,140 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,724 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
11 Previous Clinical Trials
467 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02573493 — Phase 2
Head and Neck Cancers Research Study Groups: Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT, Arm 2: nab-Paclitaxel (A) + CRT, Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02573493 — Phase 2
Cisplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02573493 — Phase 2
~11 spots leftby May 2025
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