Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx Cancer
Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)
3 other identifiers
interventional
26
1 country
1
Brief Summary
This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2013
Typical duration for phase_2
1 active site
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
December 26, 2013
CompletedFirst Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2017
CompletedAugust 14, 2018
August 1, 2018
3 years
January 27, 2014
August 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.
From date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause, assessed at 2 years
Secondary Outcomes (7)
Overall survival
The time from registration to death, assessed up to 5 years
Local-regional control
2 years
Incidence of mucosal and esophageal >= grade 3 toxicity graded according to the National Cancer Institute Common Terminology for Adverse Events version 4.0 (NCI CTCAE v4.0)
Up to 12 weeks after chemoradiotherapy
Incidence of other >= grade 3 toxicity graded according to NCI CTCAE v4.0
Up to 12 weeks after chemoradiotherapy
PTD
Up to 5 years
- +2 more secondary outcomes
Study Arms (1)
Treatment (paclitaxel, carboplatin, IMRT)
EXPERIMENTALINDUCTION: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY: At least 2 weeks after completion of induction chemotherapy, patients receive paclitaxel IV over 1 hour weekly and undergo IMRT daily 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Undergo IMRT
Ancillary studies
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of HPV-positive squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry
- Clinical stage III or IV disease; note: patients with M1 tumors are not eligible
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination within 4 weeks prior to registration, including assessment of weight loss in past 6 months
- Chest x-ray (or chest computed tomography \[CT\] scan or positron emission tomography \[PET\]/CT scan) within 6 weeks prior to registration
- CT scan or magnetic resonance imaging (MRI) of the head and neck (of the primary tumor and neck nodes) and PET/CT scan
- Zubrod performance status 0-1
- Absolute neutrophil count (ANC) \> 1,800 cells/mm\^3
- Platelets \> 100,000 cells/mm\^3
- Hemoglobin (Hgb) \> 8.0 g/dl (note: the use of transfusion or other intervention to achieve Hgb \> 8.0 g/dl is acceptable)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2x the upper limit of normal
- Serum creatinine =\< 1.5 mg/dl or institutional upper limit of normal
- Creatinine clearance (CC) \>= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
- Negative serum pregnancy test within 7 days prior to start of induction chemotherapy (ICT) for women of childbearing potential
- Women of childbearing potential and male participants are counseled on birth control and must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment)
- +1 more criteria
You may not qualify if:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Patients with simultaneous primaries or bilateral tumors are excluded
- Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded
- Patients with unknown primary tumor sites are excluded
- Patients who present with a cervical lymph node metastasis of unknown primary origin
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy that would result in overlap of radiation therapy fields
- Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses, or salivary glands
- Recurrent head and neck cancer
- Current uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction
- Congestive heart failure with left ventricular ejection fraction \< 20%
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Active lupus erythematosus or scleroderma with ongoing physical manifestations
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Related Publications (1)
Chen AM, Felix C, Wang PC, Hsu S, Basehart V, Garst J, Beron P, Wong D, Rosove MH, Rao S, Melanson H, Kim E, Palmer D, Qi L, Kelly K, Steinberg ML, Kupelian PA, Daly ME. Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):803-811. doi: 10.1016/S1470-2045(17)30246-2. Epub 2017 Apr 20.
PMID: 28434660DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allen Chen
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2014
First Posted
January 29, 2014
Study Start
December 26, 2013
Primary Completion
January 9, 2017
Study Completion
January 9, 2017
Last Updated
August 14, 2018
Record last verified: 2018-08