Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Small Cell Lung Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pancreatic Neoplasms

Sarcoma

Recurrence

Carcinoma, Renal Cell

Head and Neck Neoplasms

Osteosarcoma

Uterine Neoplasms

Kidney Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Small Cell Lung Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Gemcitabine

Bortezomib

Antimetabolites

Cola

Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose on day 1 and day 8 of a 21 day cycle.

Bortezomib will be given 1 hour after gemcitabine by IVP over 3 to 5 seconds followed by a standard saline on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.

Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m\^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.

bortezomib

Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m\^2) on day 1 and day 8 of a 21 day cycle.

gemcitabine hydrochloride

Arkadiusz Dudek, MD

RATIONALE: Bortezomib may stop the growth of solid tumors by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and gemcitabine in treating older patients with advanced solid tumors.

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of weekly bortezomib and gemcitabine in treating elderly patients with advanced solid tumors.

Secondary

* To characterize the quantitative and qualitative toxicities of bortezomib and gemcitabine in these patients.
* To obtain preliminary information about the anti-tumor activity of bortezomib and gemcitabine.
* To characterize gemcitabine and metabolite pharmacokinetics in patients receiving concurrent bortezomib therapy.

OUTLINE: This is a phase I dose escalation study of bortezomib and gemcitabine.

Patients receive gemcitabine intravenously (IV) over 30 minutes followed 1 hour later by bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and bortezomib until the maximum tolerated dose of the combination is determined.

Blood is collected periodically for pharmacokinetic and pharmacogenetic studies.

After completion of study treatment, patients are followed every 3 months for up to 1 year.

Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors

Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227)

A minimum of a 3 week period (1 cycle) must be completed by all patients within a dose level before dose escalation to the next level may occur. A cycle is defined as treatment day 1 and 8 with follow-up through day 21.

Toxicity will be graded using the NCI's Common Terminology Criteria for Adverse Events (CTCAE 3.0)

The best overall response is the best response recorded from the start of treatment until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since the treatment began.

Pharmacokinetics will be done in conjunction with the dosing day 1 of cycle 1 whenever possible.

Masonic Cancer Center, University of Minnesota

Neoplasms, Connective and Soft Tissue

Cetuximab

Antineoplastic Agents, Immunological

The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.

A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.

cetuximab

The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bortezomib together with cetuximab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).

Secondary

* To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.

OUTLINE: This is a dose-escalation study of bortezomib.

Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically for up to 1 year.

Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR

The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.

The best overall response is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors	NCT00620295	Breast Cancer Colorectal Canc... Head and Neck C... Kidney Cancer Lung Cancer Ovarian Cancer Pancreatic Canc... Prostate Cancer Sarcoma	bortezomib gemcitabine hyd...	70 Years -	Masonic Cancer Center, University of Minnesota
Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors	NCT00622674	Breast Cancer Colorectal Canc... Head and Neck C... Kidney Cancer Lung Cancer Pancreatic Canc... Sarcoma Unspecified Adu...	cetuximab bortezomib	18 Years -	Masonic Cancer Center, University of Minnesota
Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors	NCT00620295	Breast Cancer Colorectal Canc... Head and Neck C... Kidney Cancer Lung Cancer Ovarian Cancer Pancreatic Canc... Prostate Cancer Sarcoma	bortezomib gemcitabine hyd...	70 Years -	Masonic Cancer Center, University of Minnesota

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