Neoplasms

All Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Thyroid Diseases

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cetuximab

Cisplatin

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Parathyroid Hormone

Trace Elements

Enzyme Inhibitors

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Participants will receive pemetrexed,cisplatin and cetuximab for up to 6 cycles (21 days per cycle) followed by optional maintenance of pemetrexed and cetuximab until disease progression. Optional maintenance therapy is permitted after at least 4 cycles of triplet combination therapy have been given. Cetuximab will be administered as an initial dose of 400 milligram per meter squared (mg/m\^2) intravenous (IV) infusion and as a 250 mg/m\^2 IV weekly dose thereafter.

As Standard of care dietary supplements included: 350 to 1000 micrograms (µg) oral Folic Acid 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed and 1000 µg vitamin B12 intramuscular injection (IM) during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Triplet Combination Therapy: 500 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles

Maintenance Therapy: 500mg/m\^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity

Triplet Combination Therapy: 400 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m\^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.

Maintenance Therapy: 250 mg/m\^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity

Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.

Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.

Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST

The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

A 12 patient safety lead will evaluate side effects in patients receiving at least 2 cycles of the combination pemetrexed, cisplatin and cetuximab.

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

OS defined as the time from the date of first dose of study drug to the date to death from any cause.

CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).

EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 \[no limitation\], 2 \[some limitation\] or 3 \[severe or complete limitation\] in 5 dimensions \[mobility, self-care, usual activities, pain/comfort and anxiety/depression\]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).

PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.

Eli Lilly and Company

Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

Pemetrexed Cisplatin Cetuximab

Age Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

Belgium

France

Germany

Italy

Spain

United Kingdom

Region of Enrollment

Chief Medical Officer

Protocol Qualified (PQ) Population: all randomized and treated participants

Progression Free Survival (PFS)

PQ Population: all randomized and treated participants

Overall Survival (OS)

PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.

Percent of Participants With a Partial Response (PR) or a Complete Response (CR)

Change at End of Triplet Therapy (n=23)

Change at End of Maintenance Therapy (n=11)

PQ Population: all randomized and treated participants with evaluable data for each category

Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy

Change at End of Triplet Therapy (n=29)

Change at End of Maintenance Therapy (n=15)

PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.

Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy

NOD-Change at Triplet Cycle 2 (n=53)

NOD-Change at Triplet Cycle 4 (n=41)

NOD-Change at Triplet Cycle 6 (n=24)

NOD-Change at Maintenance Cycle 1 (n=23)

NOD-Change at Maintenance Cycle 3 (n=10)

NOD-Change at Maintenance Cycle 5 (n=6)

NOD-Change at Maintenance Cycle 7 (n=5)

EIP-Change at Triplet Cycle 2 (n=46)

EIP-Change at Triplet Cycle 4 (n=37)

EIP-Change at Triplet Cycle 6 (n=22)

EIP-Change at Maintenance Cycle 1 (n=23)

EIP-Change at Maintenance Cycle 3 (n=10)

EIP-Change at Maintenance Cycle 5 (n=6)

EIP-Change at Maintenance Cycle 7 (n=5)

UOS-Change at Triplet Cycle 2 (n=53)

UOS-Change at Triplet Cycle 4 (n=41)

UOS-Change at Triplet Cycle 6 (n=24)

UOS-Change at Maintenance Cycle 1 (n=23)

UOS-Change at Maintenance Cycle 3 (n=10)

UOS-Change at Maintenance Cycle 5 (n=6)

UOS-Change at Maintenance Cycle 7 (n=5)

PQ Population: all randomized and treated participants with evaluable data at respective timepoint.

Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)

Pemetrexed 500 milligram per meter squared (mg/m\^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles.

At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.

Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

Pemetrexed + Cisplatin + Cetuximab

Overall Study

Nutritional and Metabolic Diseases

Rare Diseases

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Hypercalcemia

Parathyroid Diseases

Endocrine System Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Endocrine Gland Neoplasms

Primary Hyperparathyroidism

Parathyroid adenoma, hyperplasia and carcinoma

Sanjay Kr Bhadada, DM

Ashutosh Kr Arya, M Sc

Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially known. Few genes have been identified and their roles are under study.

The genes which are under study by different groups are unable to give a definite direction towards the understanding of parathyroid tumorigenesis and the mechanism involved in overgrowth of parathyroid tissue. So identifying different proteins and their regulation pattern from adenomas to carcinomas will be the initial steps towards understanding the proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one can generate protein level information. In this study, using a combined approach based on 2 D gel electrophoresis and mass spectrometry (MS), the investigators propose to study a comparative proteomics to examine the changes of protein profiles in parathyroid tumor tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to understand differentially expressed proteins in patients with PHPT. This will help in understanding the disease and identifying better diagnostic and curative measures of the disease. The investigators are also planning to access nuclear morphometry changes in sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern variations from normal to parathyroid tumors.

Subjects:

All the PHPT patients attending outdoor patient clinic of Endocrinology and General Surgery department of Nehru Hospital, PGIMER, Chandigarh will be enrolled in this study.

Sample collection:

A parathyroid tissue sample will be taken from the patients undergoing for parathyroidectomy. Samples will be collected immediately after surgery, snap frozen and stored at -80oC until use. In addition 10 ml of blood will also be taken from these patients for estimating biochemical parameters.

Controls:

Normal parathyroid gland will be used as control and it will be obtained from patient undergoing thyroidectomy for multinodular goiter as an elective procedure at the institute.

Differentially Expressed Proteins in Sporadic Parathyroid Tumors

Identification of Differentially Expressed Proteins in Parathyroid Tumors and Their Clinical Correlation With the Disease

Post Graduate Institute of Medical Education and Research, Chandigarh

Associate Professor, Dept of Endocrinology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01057589	Head and Neck N...	Pemetrexed Cetuximab Cisplatin Folic Acid Vitamin B12	18 Years -	Eli Lilly and Company
Differentially Expressed Proteins in Sporadic Parathyroid Tumors	NCT01647503	Primary Hyperpa... Hypercalcemia		15 Years - 65 Years	PIMERIndia
A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01057589	Head and Neck N...	Pemetrexed Cetuximab Cisplatin Folic Acid Vitamin B12	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for parathyroid gland