Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT02524275 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 0762-14-FBNCI-2015-00587
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate of Complete or Partial Response

  The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

  At 15 weeks

Secondary Outcomes (2)

• Progression-free Survival

  First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years

• Survival

  First date of therapy until the date of death from any cause, assessed up to 5 years

Study Arms (1)

Treatment (docetaxel, capecitabine)

EXPERIMENTAL

Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Capecitabine; Drug: Docetaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (docetaxel, capecitabine)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (docetaxel, capecitabine)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (docetaxel, capecitabine)

Questionnaire Administration OTHER

Ancillary studies

Treatment (docetaxel, capecitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma of the head and neck with measurable disease that is either recurrent after attempted cure with surgery and/or radiation therapy or newly diagnosed disease with distant metastases or incurable at diagnosis
• Performance status: Karnofsky score \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
• Age 19 years or older (age of consent in Nebraska); age 18 years or older (applicable to states where the age of majority is 18)
• No prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or fluorouracil \[5-FU\]) as part of that regimen
• White blood cell (WBC) count \>= 3,500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Serum creatinine less than 1.5 times the upper limits of normal
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal
• Serum alkaline phosphatase less than 2.5 times the upper limits of normal
• Serum total bilirubin is less than or equal to the upper limits of normal
• Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =\< 1.5 x upper limit of normal unless subject is receiving anticoagulants; if the subject is on anticoagulation therapy, levels should be within therapeutic range
• Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
• Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
• The subject must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

You may not qualify if:

• Prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or 5-FU) as part of that regimen
• Allergy to either of the study medications or 5-fluorouracil
• Simultaneous participation in other therapeutic clinical trials will not be allowed
• If a subject is receiving allopurinol/cimetidine/antivirals they must be discontinued prior to starting this protocol
• Prior malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levels (gonadotropin-releasing hormone \[GnRH\] analogs or androgen receptor blockers acceptable); or other cancers from which the subject has been disease-free for at least five years
• Uncontrolled intercurrent illnesses including, but not limited to symptomatic congestive heart failure, severe oxygen dependent chronic obstructive pulmonary disease, unstable angina or uncontrolled cardiac arrhythmia that could jeopardize the subject?s ability to receive the chemotherapy described in the protocol safely
• Pregnant and nursing women are excluded from this study
• Inability to co-operate with the study visit schedule and other requirements of the protocol
• Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator?s opinion, may interfere with protocol adherence or a subject?s ability to give informed consent

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (3)

Faith Regional Health Services Carson Cancer Center

Norfolk, Nebraska, 68701, United States

Location

Omaha Veterans Administration Medical Center

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Apar Ganti
• Organization: University of Nebraska Medical Center

aganti@unmc.edu

402-559-8121

Study Officials

• Apar Ganti, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 12, 2015
• First Posted: August 14, 2015
• Study Start: March 30, 2015
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: September 8, 2023
• Results First Posted: September 1, 2022

Record last verified: 2023-08

Locations

US (3)