A Phase 2 interventional study of Docetaxel and Cisplatin in Cancer, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.
The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 39 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
Drug: Docetaxel · Drug: Cisplatin · Drug: Cetuximab · Procedure: Radiation Therapy
Docetaxel 75 mg/m\^2 IV over 1 hour, day 1
Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
Also known as: (Erbitux or C225)
Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time frame: Up to 36 months
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time frame: Up to 36 months
Progression-free Survival (PFS)
PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.
Time frame: Up to 36 months
2-year Overall Survival (OS)
Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
Time frame: Up to 24 months
3-year Overall Survival (OS)
Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
Time frame: Up to 36 months
Quality of Life (QOL)
Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days." The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
Time frame: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
EGFR-related Serum Markers
Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.
Time frame: Up to 36 months
| Milestone | Head and Neck Cancer Patients |
|---|---|
| Started | 39 |
| Completed | 37 |
| Not completed | 2 |
| Milestone | Head and Neck Cancer Patients |
|---|---|
| Started | 37 |
| Completed | 33 |
| Not completed | 4 |
| Milestone | Head and Neck Cancer Patients |
|---|---|
| Started | 31 |
| Completed | 17 |
| Not completed | 14 |
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
| percentage of participants | Head and Neck Cancer Patients |
|---|---|
| Objective Response Rate (ORR) | 86 (75 to 98) |
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
| percentage of participants | Head and Neck Cancer Patients |
|---|---|
| Objective Response Rate (ORR) | 100 (91 to 100) |
PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.
| percentage of participants | Head and Neck Cancer Patients |
|---|---|
| two-year PFS | 70 (53 to 82) |
| three-year PFS | 70 (53 to 82) |
Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
| percentage of participants | Head and Neck Cancer Patients |
|---|---|
| 2-year Overall Survival (OS) | 84 (68 to 93) |
Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
| percentage of participants | Head and Neck Cancer Patients |
|---|---|
| 3-year Overall Survival (OS) | 74 (54 to 86) |
Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days." The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
| units on a scale | Head and Neck Cancer Patients |
|---|---|
| FACT-G Total Score Pre-treatment | 77.4311 ± 16.56741 |
| FACT-G Total Score Post-induction | 75.6303 ± 15.68977 |
| FACT-G Total Score 3 months after XPE | 71.3864 ± 17.51042 |
| FACT-G Total Score 12 months after XPE | 86.6702 ± 18.82226 |
| FACT-HN Pre-treatment | 25.7000 ± 6.74230 |
| FACT-HN Post-induction | 25.1250 ± 7.42332 |
| FACT-HN 3 months after XPE | 19.4545 ± 5.01167 |
| FACT-HN 12 months after XPE | 24.5263 ± 7.50088 |
Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.
Results for this outcome have not been posted.
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Head and Neck Cancer Patients | — | 32/39 (82.1%) | 39/39 (100%) |
| Event | Head and Neck Cancer Patients |
|---|---|
| Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders | 13/39 |
| Leukocytes (total WBC)Blood and lymphatic system disorders | 6/39 |
| Magnesium, serum-low (hypomagnesemia)Investigations | 6/39 |
| Weight lossInvestigations | 3/39 |
| Rash: dermatitis associated with radiation, RadiationSkin and subcutaneous tissue disorders | 3/39 |
| NauseaGastrointestinal disorders | 2/39 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 2/39 |
| AnorexiaMetabolism and nutrition disorders | 2/39 |
| Pain, Throat/pharynx/larynxRespiratory, thoracic and mediastinal disorders | 2/39 |
| Rash: dermatitis associated with radiation, ChemoradiationSkin and subcutaneous tissue disorders | 2/39 |
| Event | Head and Neck Cancer Patients |
|---|---|
| Fatigue (asthenia, lethargy, malaise)General disorders | 36/39 |
| Dysphagia (difficulty swallowing)Gastrointestinal disorders | 31/39 |
| NauseaGastrointestinal disorders | 27/39 |
| Mucositis/stomatitis (clinical exam), Oral cavityGastrointestinal disorders | 26/39 |
| Pain, Oral cavityGastrointestinal disorders | 26/39 |
| Hair loss/alopecia (scalp or body)Skin and subcutaneous tissue disorders | 26/39 |
| HemoglobinBlood and lymphatic system disorders | 25/39 |
| Magnesium, serum-low (hypomagnesemia)Metabolism and nutrition disorders | 23/39 |
| VomitingGastrointestinal disorders | 21/39 |
| Leukocytes (total WBC)Investigations | 19/39 |
| Age, Continuous(years) | Head and Neck Cancer Patients |
|---|---|
| Median | 55 (21 to 74) |
| Sex: Female, Male(Participants) | Head and Neck Cancer Patients |
|---|---|
| Female | 5 |
| Male | 34 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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