Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Docetaxel (Taxotere)

Daniel A. Hamstra, M.D., Ph.D.

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.

There is no treatment proven more effective for clinically localized prostate cancer than radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly utilized as attempted salvage treatment for patients who develop a rising PSA (Prostate Specific Antigen) after prostatectomy and have no evidence of metastatic disease. This study is designed to determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy will result in improved disease control and survival rates over those obtained with radiotherapy alone in the treatment of men with biochemical recurrence after radical prostatectomy.

Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.

To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening

The number of patients that have local disease recurrence by imaging and clinical findings.

Sanofi

University of Michigan Rogel Cancer Center

Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Age, Continuous

Sex: Female, Male

Dr. Daniel Hamstra

Percentage of Patients Alive Without Progression at 4 Years

Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less

Patients that experience at least 1 G1 toxicity

Patients that experience at least 1 G2 toxicity

Patients that experience at least 1 G3 toxicity

Patients that experience at least 1 G4 toxicity

The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities

The Number of Patients That Experience Evidence of Local Recurrence

The Number of Patients Alive

Overall Study

Anti-Inflammatory Agents

Anti-Infective Agents

Prednisone

Sirolimus

Temsirolimus

MTOR Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Starting doses of Docetaxel 30 mg/m\^2 IV every 3 weeks + Sirolimus 1 mg daily

Starting dose 30 mg/m\^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.

Starting dose 1 mg daily by mouth 1 time a day.

Sirolimus (Rapamycin)

5 mg by mouth twice a day with prostate cancer.

Filip Janku, MD, PHD

The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer.

Researchers also want to find highest tolerated dose of the combination of docetaxel, sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of both drug combinations will also be studied.

The Study Drugs:

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in tumor tissue as well.

Sirolimus is designed to block a protein called mammalian target of rapamycin (mTOR) inside the cancer cell.

Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with chemotherapy to treat cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of docetaxel and sirolimus based on when you joined this study. Up to 12 dose levels of docetaxel and sirolimus will be tested. Three (3) to 6 participants will 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 docetaxel and sirolimus is found. Once the highest tolerable dose of docetaxel and sirolimus is found, up to 12 more patients may be enrolled to further study the safety of the drug at each of that dose.

If you have prostate cancer, you will also receive prednisone. All participants who receive prednisone will receive the same dose level.

Study Drug Administration:

Each study cycle is 21 days.

Everyday, you will take sirolimus by mouth 1 time a day. Sirolimus can be taken with or without food, but should be taken at the same time everyday.

On Day 1 of every cycle, you will receive docetaxel by vein over about 1 hour.

If you are taking prednisone, you will take it 2 times every day by mouth with food and water.

Study Visits:

Every week for the first 3 weeks and then about every 3 weeks, blood (about 5 teaspoons) will be drawn for routine tests. You will also have a physical exam.

Every 6 weeks, women who are able to have children will have blood drawn for a pregnancy test.

About every three weeks, blood (about 5 teaspoons) will be drawn for routine tests, to check your kidney function, and for biomarker tests.

About every 6 weeks, you will have a CT scan and x-ray to check the status of the disease.

Length of Study:

You will be on study for as long as you are benefitting. You will be taken off the study if the disease gets worse or you experience intolerable side effects.

Follow-Up:

If you experience intolerable side effects, you will be followed until the side effect has resolved or the side effect does not continue to improve or get worse. The study doctor will tell you what tests will need to be performed.

This is an investigational study. Docetaxel is FDA approved and commercially available for the treatment of advanced cancers such as breast, lung, and prostate cancer. Sirolimus is FDA approved and commercially available for the prevention of transplant rejection in kidney transplant patients. Prednisone is FDA approved and commercially available for the treatment of prostate cancer when given with docetaxel.

The combination of docetaxel and sirolimus, with or without prednisone, to treat advanced cancer is investigational. Most patients in this study will receive docetaxel and sirolimus. However, if you have prostate cancer, you will receive docetaxel, prednisone, and sirolimus.

Up to 68 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Docetaxel and Sirolimus in Patients With Advanced Malignancies

A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies

M.D. Anderson Cancer Center

Symptoms and General Pathology

Rare Diseases

Recurrence

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Dermatologic Agents

Irinotecan

Dexamethasone

Dexamethasone acetate

Taxane

Maleic acid

Pheniramine

Topoisomerase I Inhibitors

Enzyme Inhibitors

Combination chemotherapy of Docetaxel and Irinotecan (DI) in recurrent or refractory bone and soft tissue sarcomas.

Docetaxel and Irinotecan (DI) have different biologic targets, mode of action and mechanism of resistance. Preclinical studies have demonstrated an additive or synergistic effect of irinotecan and taxanes when used in combination in human.

Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1 Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8 Therapy consists of 3-week cycles comprising weekly treatment for 2 weeks (docetaxel on D1 and irinotecan on D1 and D8) followed by 1-week rest, and will be continued in the absence of disease progression or unacceptable toxicity.

This study : Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.

This study : Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.

Mi Mi Kwon, RN

Soon Mi Kim, RN

Byung-Kiu Park, M.D., Ph.D.

Byung-Kiu Park, M.D.,Ph.D.

The purpose of this study is to estimate the control rate (CR,PR,SD) of docetaxel and irinotecan (DI) combination chemotherapy for recurrent or refractory bone and soft tissue sarcomas.Al so, this study is to evaluate the toxicity profile of Docetaxel and Irinotecan (DI) combination chemotherapy.

Treatment setting:Hospitalization is preferred, but treatment on the outpatient base is allowed.

Regimen and premedication

1. Regimen Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1 Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8
2. Premedications Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.

Treatment interval and overall treatment period : Therapy consists of 3-week cycles comprising weekly treatment for 2 weeks (docetaxel on D1 and irinotecan on D1 and D8) followed by 1-week rest, and will be continued in the absence of disease progression or unacceptable toxicity. Maximal number of cycles is twelve, however, additional cycles may be employed only when at least PR is maintained and patients want to take more.

Treatment modifications : Toxicity is evaluated according to common terminology criteria for adverse events v3.0 (CTCAE) of the National Cancer Institute.

Next cycle is to be delayed until ANC count on the starting day of scheduled treatment is at least 750/μL and platelet count is at least 75,000/μL, when full doses of irinotecan and docetaxel will be given. Next cycle is also delayed if diarrhea of grade 2 or higher (including moderate cramping) occurs on the day when the dose is due.

Irinotecan treatment of D8 will be delayed to D10 if grade 2 or higher non-hematological toxicity occurred on the day when the dose is due. Irinotecan scheduled at D8 will be omitted if diarrhea of grade 2 or higher occurred on the D10. Doses of docetaxel and irinotecan in the subsequent cycles are reduced by 20% for febrile grade 4 neutropenia (ANC\<500/μL). Subsequent dose will be reduced by 20% for the recurrent toxicity. G-CSF is allowed if clinically indicated according to the ASCO guideline (22). Dose of docetaxel in the subsequent cycles are reduced by 20% for grade 2 neurologic toxicity/recurrent fluid retention, or any grade 3 non-hematologic toxicities, including hepatotoxicity, peripheral neuropathy, stomatitis, skin eruption, myalgia, cardiac events, or hypersensitivity. Subsequent dose will be reduced by 20% for the recurrent toxicity. In patients with grade 2 or higher fluid retention syndrome, prophylactic dexamethasone will be given by 6 mg/m2 bid for 3 days. Dose re-escalation after dose reduction is not permitted. Docetaxel and Irinotecan (DI) treatment will be discontinued in patients with grade 4 non-hematological toxicities at the discretion of investigators.

Dose modification schedule : Docetaxel and Irinotecan (DI) dose adjustment within a cycle will be made following the guidelines shown in Table 1 and 2 based on weekly WBC count and criteria for adverse events v3.0 (CTCAE).

Trial of Docetaxel and Irinotecan (DI) for Recurrent or Refractory Bone and Soft Tissue Sarcomas.

Docetaxel, Irinotecan, Recurrent, Refractory, Bone and Soft Tissue Sarcomas

National Cancer Center, Korea

Head of Center for Pediatric Oncology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Amino Acids

Trastuzumab

Mitogens

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

The phase I part of the study will include cohorts of 3 patients to investigate doses of lapatinib (750mg, 1000mg, 1250mg, 1500mg) with 75mg/m2 3- weekly docetaxel plus standard weekly doses of trastuzumab with prophylactic use of growth factors in all patients. Further cohorts may be explored with prophylactic use of growth factors at the doses stipulated in the phase I dose escalation schema

lapatinib, docetaxel, trastuzumab

Novartis Pharmaceuticals

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

Phase II part was cancelled before it started. Participants were only enrolled in the phase I part and NOT the phase II part.

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

An Open-label, Multicenter, Phase I/II Dose Escalation Study of Oral GW572016 in Combination With Docetaxel (Taxotere) Plus Trastuzumab (Herceptin) in Subjects Previously Untreated for ErbB2-overexpressing Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy	NCT00480857	Prostate Cancer	Docetaxel (Taxo...	18 Years -	University of Michigan Rogel Cancer Center
Docetaxel and Sirolimus in Patients With Advanced Malignancies	NCT01054313	Advanced Cancer	Docetaxel (Taxo... Sirolimus (Rapa... Prednisone	-	M.D. Anderson Cancer Center
Trial of Docetaxel and Irinotecan (DI) for Recurrent or Refractory Bone and Soft Tissue Sarcomas.	NCT01380275	Sarcoma	Docetaxel (Taxo... Irinotecan	5 Years - 49 Years	National Cancer Center, Korea
Docetaxel and Sirolimus in Patients With Advanced Malignancies	NCT01054313	Advanced Cancer	Docetaxel (Taxo... Sirolimus (Rapa... Prednisone	-	M.D. Anderson Cancer Center
GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer	NCT00251433	Neoplasms, Brea...	lapatinib, doce...	18 Years -	Novartis

Spots Global Cancer Trial Database for docetaxel (taxotere)