Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Pemetrexed

Albumin-Bound Paclitaxel

Paclitaxel poliglumex

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.

The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued

paclitaxel poliglumex, pemetrexed

James R Rigas, MD

This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.

Primary objective

To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

Secondary Objectives

To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

To evaluate the duration of response, time to progression, and overall survival of advanced NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.

To compare the overall response rate using three-dimensional reconstruction of target lesions by Medical Metrx Solutions (MMS) and RECIST criteria.

Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)

Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-small Cell Lung Cancer.

CTI BioPharma

Dartmouth-Hitchcock Medical Center

The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.

Level 1

Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.

Level 2

Paclitaxel Poliglumex With Pemetrexed

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

James Rigas, MD

Stable Disease

Progressive Disease

To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.

Time to Progression

Overall Survival

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Gemcitabine

Antimetabolites

CT-2103 135 mg/m\^2 intravenous (IV) on Day 1. Gemcitabine 1000 mg/m\^2 IV on Day 1 and 8.

CT-2103

Marjorie Green, MD

The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The safety and effectiveness of this combination will also be studied. This clinical trial will be offered to patients who are being considered for treatment with gemcitabine. Research lab samples and research biopsies will not be requested as part of this study.

CT-2103 is a chemotherapy drug designed to deliver an active chemotherapy medication (paclitaxel) inside of tumor cells. Gemcitabine is FDA approved for the treatment of breast cancer.

Before you can start receiving drug on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. You will have a CT scan of the chest and abdomen, a bone scan, and a chest x-ray performed to document the size and location of the tumor(s). Blood (about 2 tablespoons) will be drawn for routine tests. Women who are able to have children must have a negative blood-pregnancy test.

If you are found to be eligible to take part in this study, you will be assigned to a dose of CT-2103. Participants in this study will be enrolled in groups of 3. The first group will receive the lowest dose of CT-2103. Each new group of patients will receive a higher dose until the highest safe dose is found. The dose that you receive will depend on how many patients have received CT-2103 before you. You will only be assigned to one dose level, and you will stay at this same dose level for the entire study unless you have a serious side effect that requires the dose to be decreased or stopped. All participants will receive the same dose of gemcitabine, though it too may be lowered if severe side effects occur.

Both CT-2103 and gemcitabine are given through a vein. On the first day of your therapy (called 'Day 1'), you will receive a routinely given medication, ondansetron (Zofran), that will help decrease the risk of nausea. About 30 minutes later, CT-2103 will be given over 10-20 minutes followed by gemcitabine over 30 minutes.

One week later ('Day 8'), you will receive gemcitabine through the vein over about 30 minutes. You will return to see your doctor 3 weeks after your first dose of chemotherapy ('Day 21'), and then this pattern or cycle of treatment will be given again.

You will continue on therapy as long as the cancer is being controlled and you are not having unexpected or intolerable side effects. All chemotherapy will be given at M. D. Anderson.

You will have blood (about 2 tablespoons) collected once a week while you are on study to monitor the effects of chemotherapy on your bone marrow and liver and kidney function. You will see your doctor every 3 weeks to monitor how you are tolerating the therapy. At these visits, your doctor will discuss any symptoms you are having, and you will have a physical exam. If you are taking warfarin (Coumadin) you will need to have blood (about 1 tablespoon) collected three times a week to monitor you warfarin levels.

After each 6 weeks of chemotherapy, you will have repeat scans to evaluate the effects of the study drugs upon your cancer.

Once you have stopped taking therapy with CT-2103 and gemcitabine, you will be asked to return to see your physician in about 6 weeks to evaluate how you are doing and to find out if there has been any additional change in the cancer. You will have a complete medical history and physical exam. You will have a CT scan of the chest and abdomen, a bone scan, and a chest x-ray performed to document the size and location of the tumor(s).

This is an investigational study. Gemcitabine is FDA approved for the treatment of breast cancer when given in combination with paclitaxel. Gemcitabine will not be provided free of charge. CT-2103 is not yet FDA approved and will be provided free of charge during the study. Any laboratory testing that is not standard of care will be paid for by the supporting company. About 18 women will take part in this study. All will be enrolled at M. D. Anderson.

CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer

A Phase I Study of CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer

MTD defined as the level of CT-2103 at which 2 out of 6 patients had dose limiting toxicity (DLT) where the primary DLT events of CT-2103 are uncomplicated neutropenia, febrile neutropenia, and/or grade 3 neuropathy. Assessments during the first cycle of therapy, where cycle is 21 days.

Evaluation of response in participants with measurable disease after each 6 weeks of chemotherapy

M.D. Anderson Cancer Center

CT-2103 (Xyotax)

Lawrence N. Shulman, MD

The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.

* Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
* Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
* Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
* Additional blood work will be performed once per week after the first two doses of CT-2103.
* The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)	NCT00487669	Advanced Non-sm...	paclitaxel poli...	18 Years -	Dartmouth-Hitchcock Medical Center
CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer	NCT00270907	Metastatic Brea... Breast Cancer	CT-2103 Gemcitabine	18 Years -	M.D. Anderson Cancer Center
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer	NCT00148707	Breast Cancer Metastatic Brea...	CT-2103 (Xyotax...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for xyotax

Every month we try and update this database with for xyotax 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 xyotax

Every month we try and update this database with for xyotax 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 xyotax 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.