Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Carboplatin

Docetaxel

Cisplatin

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.

Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.

75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

150 mg by mouth daily continuously until the day before surgery.

Erlotinib

Placebo

Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.

Questionnaires

Phone call made to patient 1 time each year after the end of treatment visit.

Phone Call

Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

Chemotherapy

Xiuning Le, MD

The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.

In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.

Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (also known as an Arm):

* If you are in Arm A, you will receive standard chemotherapy in combination with erlotinib.
* If you are in Arm B, you will receive standard chemotherapy in combination with a placebo.

If you are 1 of the first 30 patients to be enrolled on the study, you will have an equal chance of being assigned to either group. If you are one of the next 20 patients to be enrolled on the study, you will have a higher chance of being assigned to the group that appears to be performing better. Up to 50 more participants will then be assigned to a study group based on the results seen in the first 50 participants.

Neither you nor the study doctor will know if you are receiving erlotinib or placebo. However, if needed for your safety, the study doctor will be able to find out what you are receiving.

Study Drug Administration:

You will receive docetaxel and either cisplatin or carboplatin by vein on Day 1 of up to 3 study cycles, over about 1-2 hours. The study doctor will tell you whether you are receiving cisplatin or carboplatin. Each study cycle will be 3 weeks.

You will also take tablets of either erlotinib or placebo every day until (and including) the day before your scheduled surgery. You should take the tablets with about 1 cup (8 ounces) of water. You should take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal. You should take the tablet at around the same time each day, preferably in the morning. Your eating habits around the time you take the tablet should stay the same while you are on study. lf you vomit, and you can actually see the tablet, you may take another tablet. If not, you should not take another tablet until your next scheduled dose.

You will continue to take erlotinib or placebo daily until the day prior to surgery (including the day prior to surgery).

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

On Day 1 of each Cycle, you will receive the study drugs, as described above.

Within 7 days before Cycles 2 and 3:

* You will have a physical exam.
* You will be asked about your current smoking status and tobacco use.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.

At least 14 days after the last dose of chemotherapy:

* You will have a physical exam.
* You will be asked about your current smoking status and tobacco use.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.
* You will have an MRI or CT scan of the head and neck. If the study doctor thinks it is needed, additional imaging scans may be performed.
* You will complete a questionnaire about how you feel about different aspects of your daily life. It should take you about 15 minutes to complete the questionnaire.
* Blood (about 1-2 teaspoons) will be drawn for biomarker and pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.

At any point while you are on study, if you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Surgery:

After you stop taking the study drug/placebo, you will have the surgery you were already scheduled to receive. You will sign a separate consent form that describes the surgery and its risks. As part of this study, tumor tissue will be collected during the surgery and checked for the status of the disease as well as any spread of the disease.

Length of Study:

You may receive the standard chemotherapy combination for up to 3 cycles. You may take the study drug/placebo up until the day before surgery. If you have side effects from the chemotherapy, it is possible that you may stop taking the chemotherapy combination and continue to receive the study drug/placebo up until surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your active participation on the study will be over after the end-of-treatment visit.

End of Treatment Visit:

About 8 weeks after surgery, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 1-2 teaspoons) will be drawn for biomarker and PK testing.
* You will complete the questionnaire about your daily life.
* If you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Long Term Follow Up:

After the end of treatment visit, you will be called at least 1 time each year to check on how you are doing. You (or your family members or designees) may be contacted by telephone, in writing, by e-mail, or during clinic visits. It is important to keep your contact information up to date with the study staff. This information may also be collected by checking your medical record.

Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection

Pathological complete response (pCR) defined as:

1. Complete pathological response: no residual carcinoma in the primary tumor site or lymph nodes.
2. Partial response to therapy, either i) minimal residual disease/near total effect (eg, \<10% of tumor remaining) or ii) evidence of response to therapy but with 10%-50% of tumor remaining, or iii) \>50% of tumor cellularity remains evident when compared with the previous sample, although some features of response to therapy present.
3. Minimal evidence of response to therapy.

Bayesian probit model used to assess the main effect of treatment, nodal status, and biomarker, and treatment by biomarker interaction.

Astellas Pharma Inc

The Kadoorie Charitable Foundations

M.D. Anderson Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Anti-Infective Agents

Ixazomib

HIV Protease Inhibitors

Protease Inhibitors

Dose Escalation Phase: Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle starting with Dose Level 1.

Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.

Dose Expansion Phase : Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle at the maximum tolerated dose from Dose Escalation Phase.

Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.

Dose Escalation Phase Starting Dose: Ixazomib 3.0 mg on Days 1, 8, and 15 of a 28-day cycle.

Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase

Dose Escalation and Dose Expansion Phase: Erlotinib 150 mg by mouth on Days 1 - 28 of a 29 day cycle.

David S. Hong, MD

The goal of this clinical research study is to find the highest tolerable dose of the combination of ixazomib and erlotinib that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied.

This is an investigational study. Erlotinib is FDA approved and commercially available to treat non-small cell lung cancer, but its use in advanced solid cancer is considered investigational. Ixazomib is FDA approved. The study doctor can explain how the study drugs are designed to work.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of ixazomib and erlotinib based on when you join this study. Up to 4 dose levels of ixazomib will be tested. Up to 18 participants may be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ixazomib is found.

All participants will receive the same dose of erlotinib.

Once the highest tolerable dose is found, up to 18 participants will be enrolled at that dose level as an expansion group.

The dose of the study drug combination that you receive may be lowered if you have intolerable side effects.

Study Drug Administration Each study cycle is 28 days.

You will take ixazomib capsules by mouth on Days 1, 8, and 15 of each cycle.

You will take erlotinib tablets by mouth on Days 1-28 of each cycle.

You should swallow ixazomib capsules whole with 8 ounces (1 cup) of water. Each capsule should be swallowed separately with a sip of water. You should also swallow erlotinib tablets whole with water. You should take the ixazomib and erlotinib doses at the same time.

Do not break, chew, or open the capsules or tablets. Each dose should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 72 hours (ixazomib) or 12 hours (erlotinib) away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose.

Your dose of study drug may be changed and/or you may be given drugs to help control the side effects.

Study Visits:

Cycle 1:

Week 1:

* You will have a physical exam.
* Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.
* If you can become pregnant, leftover blood (about 1 teaspoon) and/or urine will be collected for a pregnancy test.
* During Days 1, 2, 3, 5, and 8, blood (about 1-3 teaspoons) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.

Week 2:

°Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.

Week 3:

* You will have a physical exam.
* Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.

Cycle 2 and Beyond:

Week 1:

* You will have a physical exam.
* Blood (about 6 teaspoons) and urine will be collected for routine tests. The blood sample will also be used for liver and kidney function tests.
* If you can become pregnant, part of the routine blood or urine test will be used for a pregnancy test. To continue on this study, you must not be pregnant.

Week 4:

* You will have a physical exam.
* Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.
* On Day 28 of each cycle, if the doctor thinks it is needed, you will have an EKG.
* At the end of every other cycle (Cycles 2, 4, 6, and so on), you will have imaging scans (either CT scans or MRI) performed to check the status of the disease.

If you have side effects or abnormal test results while on study, you may be asked to return to the clinic for more tests until the side effects or abnormal test results improve.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop new health problems, or if you are no longer able to follow study directions.

Your participation on the study will be over after the end-of-study visit.

End of Study Visit:

Within 30 days after your last dose of the study drugs, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.
* Urine will be collected for routine tests.

Study of Ixazomib and Erlotinib in Solid Tumors

A Phase I Study of Ixazomib and Erlotinib in Advanced Solid Tumor Patients

MTD defined by dose limiting toxicities (DLTs) that occur during the first cycle.

Dose limiting toxicity (DLT) defined as

1. Any Grade 3 or 4 non-hematologic toxicity as defined in the NCI CTCAE.
2. Any Grade 4 hematologic toxicity lasting two weeks or longer (as defined by the NCI-CTCAE), despite supportive care.
3. Grade 4 nausea, vomiting or diarrhea \> 5 days despite maximum anti-nausea regimens.

Tumor response of this combination per RECIST version 1.1.

Millennium: The Takeda Oncology Company

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Paclitaxel

Albumin-Bound Paclitaxel

Participants with wild-type EGFR mutation to be randomized, and may receive this regimen.

Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.

Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.

Participants with EGFR mutation to receive this regimen. Participants with wild-type EGFR mutation to be randomized, and may receive this regimen.

Phase I: Erlotinib 150 mg by mouth every day throughout radiation, except for chemotherapy day. Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.

Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.

Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle.

Phase II: Maximum tolerated dose from Phase I.

Onartuzumab

Phase I and II: 150 mg by mouth every day throughout radiation, except for chemotherapy day.

Phase I and II: 45 mg/m2 by vein once a week throughout radiation for 7 weeks.

Phase I and II: AUC 2 by vein once a week throughout radiation for 7 weeks.

Phase I and II: Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.

Radiation Therapy

James Welsh, MD

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel and carboplatin) to patients with NSCLC.

The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to control NSCLC. The safety of this drug will also be studied.

Study Groups:

If you are found to be eligible to take part in this study and you have an EGFR mutation, you will be enrolled in Arm A. If you have the wild-type EGFR, you will be randomly assigned (as in the flip of a coin) to either Arm B or C. You will have an equal chance of being enrolled in either arm.

* If you are in Arm A, you will receive standard chemoradiation, erlotinib, and onartuzumab.
* If you are in Arm B, you will receive standard chemoradiation, erlotinib, and onartuzumab.
* If you are in Arm C, you will receive standard chemoradiation and onartuzumab only.

If you are assigned to Arm A or B, you will receive standard chemoradiation, erlotinib, and onartuzumab. You will be assigned to a dose level of onartuzumab based on when you join this study. After the first dose level of onartuzumab is given, you will be watched for 2 weeks after the end of radiation treatment to check for any serious side effects at that dose level. If any participants in this first group have intolerable side effects, a lower dose combination of the study drugs may be tested. Once the highest tolerable dose is found, extra participants will receive onartuzumab at that dose level.

All participants in Arms A and B will receive the same dose level of erlotinib.

Study Drug Administration:

All participants will receive onartuzumab by vein on Day 1 of each 3-week cycle. The first infusion should be given over about 60 minutes. If the infusion is tolerated, other doses will be given over about 30 minutes.

You will receive paclitaxel and carboplatin by vein over about 6 hours 1 time a week for 7 weeks. You will receive a separate consent form for chemoradiation, which will describe the procedure and risks in more detail.

If you are taking erlotinib, it should be taken by mouth with about 1 cup of water. You should take erlotinib at about the same time every day, at least 1 hour before a meal and at least 2 hours after a meal.

Study Visits:

One (1) time each week:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests. If you are taking Coumadin or a similar drug, this blood will also be used to check how well your blood clots.

Length of Study:

You may continue taking onartuzumab until you complete radiation therapy. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over 4 years after your last dose of study drug.

Follow-Up:

You will have follow-up visits around 30 days after your last dose of study drug, every 3 months for 2 years, and then every 4 months for the next 2 years. During these visits:

* You will have a physical exam.
* You will have a CT or PET scan to check the status of the disease.
* If you are taking Coumadin or a similar drug, blood (about 2 teaspoons) will be drawn to check how well your blood clots.

You will be called about every 4 weeks and asked how you are doing for as long as your doctor thinks it is needed.

This is an investigational study. Onartuzumab is not FDA approved or commercially available. It is currently being used for research purposes only. Erlotinib, carboplatin, and paclitaxel are all FDA approved and commercially available for the treatment of NSCLC, but their use in this study is investigational. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how the study drugs are designed to work.

Up to 90 participants will take part in this study. All will be enrolled at MD Anderson.

Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)

Phase I/II Trial Using a Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)

Maximum tolerated dose measured by the number and percent of patients experiencing dose-limiting toxicity (DLT). DLT defined as grade 3 or worse non-hematological toxicities or grade 4 or worse hematological toxicities (including all toxicities attributed to chemoradiation occurring up to 14 days of the end of radiation therapy).

Progression-free survival defined by 6-month progression free survival. Response is taken to be complete response (CR) or partial response (PR) using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection	NCT01927744	Head and Neck C...	Docetaxel Erlotinib Placebo Questionnaires Phone Call Chemotherapy	18 Years -	M.D. Anderson Cancer Center
Study of Ixazomib and Erlotinib in Solid Tumors	NCT02942095	Solid Tumors	Ixazomib Erlotinib	18 Years -	M.D. Anderson Cancer Center
Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)	NCT02044601	Lung Cancer	Onartuzumab Erlotinib Paclitaxel Carboplatin Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Study of Ixazomib and Erlotinib in Solid Tumors	NCT02942095	Solid Tumors	Ixazomib Erlotinib	18 Years -	M.D. Anderson Cancer Center
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection	NCT01927744	Head and Neck C...	Docetaxel Erlotinib Placebo Questionnaires Phone Call Chemotherapy	18 Years -	M.D. Anderson Cancer Center
Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)	NCT02044601	Lung Cancer	Onartuzumab Erlotinib Paclitaxel Carboplatin Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)	NCT02044601	Lung Cancer	Onartuzumab Erlotinib Paclitaxel Carboplatin Radiation Thera...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cp358774

Every month we try and update this database with for cp358774 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cp358774

Every month we try and update this database with for cp358774 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cp358774 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.