Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Head and Neck Neoplasms

Mouth Neoplasms

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Metastatic Squamous Neck Cancer With Occult Primary

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Fluorouracil

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

fluorouracil

gemcitabine hydrochloride

paclitaxel

radiation therapy

Athanassios Argiris, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced and/or recurrent head and neck cancer.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of gemcitabine when administered with paclitaxel and fluorouracil with concurrent hyperfractionated radiotherapy in patients with advanced and/or recurrent head and neck cancer. II. Determine the MTD and DLT of gemcitabine as a single agent with radiotherapy in these patients. III. Determine the efficacy of concurrent chemoradiotherapy in terms of time to progression, pattern of failure, and overall survival in patients with measurable disease. IV. Determine gemcitabine and fluorouracil pharmacokinetics in these patients.

OUTLINE: This is a dose escalation study of gemcitabine, conducted in two phases. Phase A: Patients receive fluorouracil IV continuously on days 1-5, paclitaxel IV over 1 hour on day 2, and radiotherapy administered twice daily on days 1-5. This regimen is repeated every 2 weeks for 2 courses, then gemcitabine IV over 30 minutes is added on day 2 after paclitaxel. This regimen is administered every 2 weeks for 3 courses. Patients with responsive disease may continue chemotherapy (without radiotherapy) for 2 courses beyond maximum response. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Phase B: After the MTD of gemcitabine is determined in phase A, further dose escalation of gemcitabine may be performed with concurrent radiotherapy (without fluorouracil or paclitaxel). The MTD is determined as in phase A. Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within approximately 2 years.

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer

A Phase I Study of Concomitant Chemoradiotherapy With Gemcitabine, Paclitaxel, and 5-FU for Patients With Advanced and/or Recurrent Cancer of the Head and Neck

National Cancer Institute (NCI)

Carcinoma

Cisplatin

Amifostine

Protective Agents

Radiation-Protective Agents

amifostine trihydrate

cisplatin

surgical procedure

Mitchell Machtay, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

OBJECTIVES:

* Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
* Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.

OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.

Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma

Abramson Cancer Center at Penn Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Prostatic Neoplasms

Carcinoma in Situ

Sarcoma

Hypoxia

Breast Carcinoma In Situ

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Soft Tissue Sarcoma

Inflammatory Breast Cancer

Antibodies

Immunoglobulins

Etanidazole

flow cytometry

fluorescent antibody technique

immunohistochemistry staining method

biopsy

Anthony Fyles, MD

RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment.

PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or cervical cancer or high grade soft tissue sarcoma.

OBJECTIVES: I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast, head and neck, prostate, or cervical carcinoma or high grade soft tissue sarcomas. II. Define the toxic effects of EF5 in this patient population.

OUTLINE: This is a dose-escalation study. Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 24-48 hours after EF5 treatment, patients undergo surgical resection or biopsy of tumor. Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding. Patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 12-18 months.

EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

A Phase I Trial of the Hypoxia Detection Agent EF5 (NSC 684681) in Patients With Cervix and Breast and Prostate Carcinomas, and High Grade Soft Tissue Sarcomas

University Health Network, Toronto

Respiratory Tract (Lung and Bronchial) Diseases

Substance Related Disorders

Carcinoma, Squamous Cell

Laryngeal Diseases

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Mucoepidermoid Carcinoma

Fred R. Rosen, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.

OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.

OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue 16-46 patients.

Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer

A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer

University of Illinois at Chicago

Arlene A. Forastiere, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.

OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.

OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer

Theradex

Digestive System Diseases

Pain

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Molgramostim

Sargramostim

sargramostim

quality-of-life assessment

Francis G. LeVeque, DDS

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.

OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy.
* Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week (except on days if receiving concurrent cisplatin) beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks.
* Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on the same schedule as GM-CSF in arm I.

Quality of life is assessed at baseline, and then at 3, 6, and 12 months.

Patients are followed at 3, 6 and 11 months.

PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4 years.

Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients

Radiation Therapy Oncology Group

Raj Sadasivan, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma of the head and neck. II. Determine the toxicity profile of this combination treatment in these patients. III. Assess the response rate of treatment in these patients.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3 patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are assessed for response every 2 weeks. Patients may continue treatment for up to 9 months or until disease progression.

PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of this study.

Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck

A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)

Hope Cancer Institute, Inc.

Gland and Hormone Related Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Esophageal Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Teratoma

Testicular Neoplasms

Kidney Neoplasms

Rhabdoid Tumor

Sarcoma, Clear Cell

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Small Cell Lung Cancer

Germ Cells Tumors

Fallopian Tube Cancer

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Uterine Sarcoma

paclitaxel albumin-stabilized nanoparticle formulation

gene expression analysis

laboratory biomarker analysis

pharmacological study

polymerase chain reaction

Sridhar Mani, MD

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors.

OBJECTIVES:

Primary

* To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent.

Secondary

* To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer (castrate), metastatic breast cancer, advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel.
* To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia.
* To explore the association between the CYP2C8\*3 variant and paclitaxel clearance.
* To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4, CYP3A5, SLCO1B3 (OATP8), and ABCB1 (MDR1) and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment may repeat off study every 9 weeks in the absence of disease progression or unacceptable toxicity.

Serial blood samplings are obtained at specified time points during course 1 including baseline and days 1 and 8 of course 1 for pharmacokinetic studies. Samples are also examined for genotype by PCR including variant genotypes in 2C8, CYP3A4, CYP3A5, ABCB1, ABCC2, ABCC10 and OATP1B3 genes.

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer	NCT00004097	Head and Neck C...	fluorouracil gemcitabine hyd... paclitaxel radiation thera...	18 Years -	National Cancer Institute (NCI)
Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer	NCT00003777	Head and Neck C...	amifostine trih... cisplatin fluorouracil surgical proced... radiation thera...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma	NCT00004261	Breast Cancer Cervical Cancer Head and Neck C... Prostate Cancer Sarcoma	EF5 flow cytometry fluorescent ant... immunohistochem... biopsy	18 Years - 120 Years	University Health Network, Toronto
Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer	NCT00003251	Drug/Agent Toxi... Head and Neck C... Radiation Toxic...	amifostine trih... cisplatin paclitaxel radiation thera...	18 Years -	National Cancer Institute (NCI)
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer	NCT00003327	Head and Neck C...	paclitaxel	18 Years -	National Cancer Institute (NCI)
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer	NCT00008398	Head and Neck C... Oral Complicati... Radiation Toxic...	sargramostim quality-of-life... radiation thera...	-	Radiation Therapy Oncology Group
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma	NCT00004261	Breast Cancer Cervical Cancer Head and Neck C... Prostate Cancer Sarcoma	EF5 flow cytometry fluorescent ant... immunohistochem... biopsy	18 Years - 120 Years	University Health Network, Toronto
Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck	NCT00003182	Head and Neck C...	cisplatin gemcitabine hyd...	18 Years -	National Cancer Institute (NCI)
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors	NCT00499291	Cancer	paclitaxel albu... gene expression... laboratory biom... pharmacological... polymerase chai...	18 Years - 120 Years	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for stage iv paranasal sinus and nasal cavity cancer