Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Xylometazoline

Tubulin Modulators

Antimitotic Agents

Patients receive ganetespib IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes once a week on day 1. Patients also undergo radiation therapy 5 days a week for 5.5 weeks or for a total of 28 treatments. Treatment continues for 28 treatment days (5.5 weeks) in the absence of disease progression or unacceptable toxicity

Ganetespib

Radiation Therapy

Steven Lin

This phase I trial studies the side effects and best dose of ganetespib when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-III esophageal cancer. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving ganetespib in combination with paclitaxel, carboplatin, and radiation therapy may be a better treatment for patients with esophageal cancer.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated disease (MTD) and the recommended phase II dose of ganetespib to combine with standard carboplatin and paclitaxel chemotherapy and radiotherapy in stage II-III patients with esophageal carcinoma.

SECONDARY OBJECTIVES:

I. To assess the response rate based on fludeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) +/- CT with contrast imaging response assessment after completion of chemoradiation.

II. To determine the 1 year overall survival (OS) rate. III. To determine the progression-free survival (PFS) rate. IV. To determine the pathologic complete response (pCR) rate for patients who undergo surgery.

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

Patients receive ganetespib intravenously (IV) over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes once a week on day 1. Patients also undergo radiation therapy 5 days a week for 5.5 weeks or for a total of 28 treatments. Treatment continues for 28 treatment days (5.5 weeks) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Ganetespib in Combination With Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-III Esophageal Cancer

GUARDIAN-1 Trial: A Phase 1 Study of Ganetespib in Combination With Chemoradiation for Stage II-III Esophageal Carcinoma

The MTD is defined as the dose for which the posterior mean probability of dose-limiting toxicity is closest to 30%.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Liver Neoplasms

Carcinoma, Ductal

Rectal Neoplasms

Colonic Neoplasms

Intestinal Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Liver Diseases

Pancreatic Cancer

Bile Duct Cancer

Stomach Cancer

Small Intestine Cancer

Micronutrients

Anti-Infective Agents

Ropidoxuridine

Iodine

Cadexomer iodine

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Pharmacological Study

Timothy J Kinsella

This phase I trial studies the side effects and best dose of ropidoxuridine in treating patients with gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment undergoing radiation therapy. Ropidoxuridine may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy.

PRIMARY OBJECTIVES:

I. To conduct a phase I dose escalation trial, to determine the safety and the maximum tolerated dose (MTD), of oral (po) IPdR (ropidoxuridine) given daily for 28 consecutive days with concurrent intensity-modulated radiation therapy (IMRT) in patients with advanced gastrointestinal cancers treated with palliative radiation.

SECONDARY OBJECTIVES:

I. To observe and record anti-tumor activity. II. To establish the pharmacokinetics of daily po dosing of IPdR x 28 days. III. To assess, for patients treated at the MTD, for biochemical evidence of IPdR effect in normal tissue (circulating granulocytes) and tumor tissue (in patients with accessible tumor tissue) by measuring %iododeoxyuridine (IUdR)-deoxyribonucleic acid (DNA) cellular incorporation by flow cytometry and high-pressure liquid chromatography (HPLC) analyses.

IV. To assess the use of %IUdR-DNA cellular incorporation (measured by the investigational laboratory assays of flow cytometry and HPLC) as an exploratory biomarker of IPdR for the following effects: the %IUdR-DNA tumor cell incorporation from day 8 tumor biopsies in gastrointestinal (GI) cancer patients receiving MTD doses of IPdR as an exploratory biomarker of tumor radiosensitization using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

V. To assess the use of %IUdR-DNA cellular incorporation (measured by the investigational laboratory assays of flow cytometry and HPLC) as an exploratory biomarker of IPdR for the following effects: the %IUdR-DNA cellular incorporation in patients' circulating granulocytes taken weekly during the 28-day IPdR MTD dose, on day 29, and week 8 as an exploratory biomarker of IPdR systemic toxicities to bone marrow as measured by complete blood count (CBC)/differential values.

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

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO once daily (QD) on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy

Phase I and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2'- Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Gastrointestinal Cancers

Correlate %IUdR-DNA incorporation in human gastrointestinal (GI) tumor biopsies in the proposed phase I and pharmacokinetic (PK) clinical trial in GI cancer patients receiving palliative abdominal and/or pelvic radiation therapy (RT) by linear regression.

Correlate %IUdR-DNA incorporation in human GI tumor biopsies in the proposed phase I and PK clinical trial in GI cancer patients receiving palliative abdominal and/or pelvic RT by linear regression.

Tumor response is the dependent variable and can be binomial (i.e. response versus \[vs.\] no response) or multinomial (i.e. complete response, partial response, stable disease or progressive disease) and the %IUdR-DNA incorporation is the independent variable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ganetespib in Combination With Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-III Esophageal Cancer	NCT02389751	Gastroesophagea... Malignant Neopl... Malignant Neopl... Stage IIA Esoph... Stage IIB Esoph... Stage IIIA Esop... Stage IIIB Esop... Stage IIIC Esop...	Carboplatin Ganetespib Paclitaxel Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy	NCT02381561	Advanced Bile D... Stage II Esopha... Stage II Pancre... Stage IIA Esoph... Stage IIA Pancr... Stage IIB Esoph... Stage IIB Pancr... Stage III Colon... Stage III Esoph... Stage III Gastr... Stage III Liver... Stage III Pancr... Stage III Recta... Stage III Small... Stage IIIA Colo... Stage IIIA Esop... Stage IIIA Gast... Stage IIIA Rect... Stage IIIA Smal... Stage IIIB Colo... Stage IIIB Esop... Stage IIIB Gast... Stage IIIB Rect... Stage IIIB Smal... Stage IIIC Colo... Stage IIIC Esop... Stage IIIC Gast... Stage IIIC Rect... Stage IV Colon ... Stage IV Esopha... Stage IV Gastri... Stage IV Liver ... Stage IV Pancre... Stage IV Rectal... Stage IV Small ... Stage IVA Colon... Stage IVA Liver... Stage IVA Recta... Stage IVB Colon... Stage IVB Liver... Stage IVB Recta...	Intensity-Modul... Laboratory Biom... Pharmacological... Ropidoxuridine	18 Years -	National Cancer Institute (NCI)
Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy	NCT02381561	Advanced Bile D... Stage II Esopha... Stage II Pancre... Stage IIA Esoph... Stage IIA Pancr... Stage IIB Esoph... Stage IIB Pancr... Stage III Colon... Stage III Esoph... Stage III Gastr... Stage III Liver... Stage III Pancr... Stage III Recta... Stage III Small... Stage IIIA Colo... Stage IIIA Esop... Stage IIIA Gast... Stage IIIA Rect... Stage IIIA Smal... Stage IIIB Colo... Stage IIIB Esop... Stage IIIB Gast... Stage IIIB Rect... Stage IIIB Smal... Stage IIIC Colo... Stage IIIC Esop... Stage IIIC Gast... Stage IIIC Rect... Stage IV Colon ... Stage IV Esopha... Stage IV Gastri... Stage IV Liver ... Stage IV Pancre... Stage IV Rectal... Stage IV Small ... Stage IVA Colon... Stage IVA Liver... Stage IVA Recta... Stage IVB Colon... Stage IVB Liver... Stage IVB Recta...	Intensity-Modul... Laboratory Biom... Pharmacological... Ropidoxuridine	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iia esophageal cancer ajcc v7