Clinical Trials

  Home | Cancer Information | Care Teams | Clinical Trials | Research

 

 

 

 

 

 

 

 

 

 

Top

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Top

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Top

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Top

 

Digestive System Trials

TITLE UPCI 2204: Phase II study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
DESCRIPTION The purpose of this study is to determine how docetaxel and gefitinib work when given to together and if this combination will 
slow the growth of pancreatic cancer. Patients will receive docetaxel and gefitinib for a maximum of 12 months.
ELIGIBILITY
  1. Age ≥ 18 years
  2. Histologically confirmed adenocarcinoma of the pancreas that is surgically inoperable.
  3. Patients must have had one prior chemotherapeutic regimen for advanced disease.
  4. ECOG performance status 0 – 2
  5. Patients must have normal bone marrow, liver and kidney function.
  6. No evidence of clinically active lung disease
CONTACT Linda Rath, RN   216-844-7028
TITLE E 1Y03: Master Protocol for Pharmacogenetic and Genomic Studies
DESCRIPTION The purpose of this laboratory study is to collect and study blood and tissue from patients who may be involved in other ECOG 
trials to help understand why there are differences in response to therapy.
ELIGIBILITY
CONTACT Linda Rath, RN   216-844-7028
TITLE RPCI 1204: RPCI 1204 Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer
DESCRIPTION This study aims to determine how well patients with pancreatic cancer respond to the combination of gemcitabine, capecitabine and avastin, and to determine well the drugs will be tolerated when given to patients over several months. Patients will be treated with Avastin every 3 weeks, starting on day1. Capecitabine will be taken by mouth two times a day for 14 days starting on day 1. Gemcitabine will be given on day 1 and day 8 of each cycle. Treatment will be continued until progression or toxicity or patient/physician preference up to a maximum duration of 12 months.
ELIGIBILITY
  1. Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is unresectable or metastatic. No prior systemic therapy for metastatic disease. Prior adjuvant therapy is permitted if completed > 6 months.
  2. No duodenal or gastric wall invasion
  3. No brain metastases
  4. No proteinuria
  5. Age > 18 years
  6. ECOG performance status 0 or 1.
  7. Patients must have normal bone marrow, liver and kidney function
CONTACT Linda Rath, RN   216-844-7028
TITLE CASE 8205: Pilot Study of Changes in Fat-Free Mass in Patients with Pancreatic Carcinoma
DESCRIPTION This study will evaluate a new method for the measurement of changes in the amount of muscle tissue that may occur in patients with pancreatic cancer and correlate changes in a longitudinal fashion with tumor activity. This study may help with predicting patient outcome based on these measurements.
ELIGIBILITY
  1. Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma.
  2. ECOG performance status 0-3
  3. Age > 18 years
  4. Able to stand unassisted
  5. Must not have pacemaker or implanted defibrillator
CONTACT Linda Rath, RN   216-844-7028
TITLE CASE 1205: Dose-Dense and Dose-Intense Alternating Irinotecan/Capecitabine and
Oxaliplatin/Capecitabine: Phase I in Solid Tumors and Phase II with Bevacizumab as First-Line Therapy of Advanced Colorectal Cancer
DESCRIPTION This study will determine the maximum tolerated dose of Oxaliplatin, Irinotecan, and Capecitabine when given every 2 weeks, and determine if they will lead to improved response rates as first line therapy of advanced colorectal cancer.
ELIGIBILITY
  1. ge > 18 years
  2. Phase I: Patients must have a histologically confirmed solid tumor cancer which is metastatic or locally advanced and unresectable, Phase II: Patients must have advanced colorectal cancer
  3. Life expectancy > 12 weeks
  4. Patients must have normal bone marrow, liver and kidney function
CONTACT Carolyn Mauser, RN 216-844-5071
TITLE E 5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
DESCRIPTION

This research study is being done to find out whether specific biological features (often called tumor markers or markers) seen in tests done on a colon tumors can be used to predict recurrence of tumors in patients with stage II colon cancer. The chemotherapy drugs given in combination in this study are 5-fluorouracil (5-FU), leucovorin and oxaliplatin. Researchers will look to see if adding bevacizumab to these other cancer-fighting agents is better for treating colon cancer patients, who may be at increased risk for recurrence based on the markers shown in their tumors. Researchers also want to see if adding bevacizumab will help prevent the cancer from coming back. 

ELIGIBILITY
  1. A tumor that meets certain criteria for type, size and position;
  2. No history of intra-abdominal metastases;
  3. No perforation or obstruction of the bowel;
  4. Adequate liver, kidney, and heart function and/or laboratory values;
  5. No ulcers, or serious wounds or wound healing problems, bone fractures, or non-malignant systemic disease that would exclude them from the study; 
  6. Biopsy of the tumor to evaluate two particular tumor markers; 
  7. 18 years of age or older;
CONTACT Linda Rath, RN   216-844-7028
TITLE MACM 1204  A Dose Escalation Study of OncoGel® Treatment as an Adjunctive Therapy to External Beam Radiation in Patients with Inoperable Esophageal Cancer
DESCRIPTION This study is being done to determine to safety, tolerability and pharmacokinetics of OncoGel® injected directly into the tumor in patients with inoperable esophageal cancer who are also receiving external beam radiation therapy for palliation of dysphagia symptoms.  The study medication, OncoGel® will be administered during endoscopy under standard conscious sedation techniques.  OncoGel® dosing will occur at dosing day 1 on the same day or no more than 3 days prior to the time the patient receives external beam radiation therapy.  Patients will receive external beam radiation once daily, 5 days a week, for 5.5 weeks.
ELIGIBILITY
  1. Patients must have esophageal cancer that has been histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma.
  2. Patients must have surgically or medically inoperable esophageal cancer and be able to receive external beam radiation therapy at study dosages for palliation of symptoms.
  3. Patient must have a minimum life expectancy of four months.
  4. Patients must have a baseline dysphagia grade of 3, 4 or 5.
CONTACT Linda Rath, RN   216-844-7028
TITLE EXEL 1204: A Phase III Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Flouracil (5-FU) plus Leucovorin (LV) in Subjects with Advanced Biliary Tumors Not Amenable to Conventional Surgery
DESCRIPTION This study will compare the overall survival duration for XL119 and 5-FU/LV treated subjects. Patients will be randomized to receive either XL119 or 5FU/LV. XL119 will be administered as a 1-hour infusion on days 1 through 5 of a 28-day cycle. Patients may receive up to 12 cycles of treatment. 5-FU/LV will be administered intravenously on days 1 through 5 of a 28-day cycle. 
ELIGIBILITY
  1. Patients must have histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach.
  2. Patients must not have received prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study).
  3. Patients must have a life expectancy of at least 12 weeks.
  4. Patents must have normal liver, kidney and bone marrow function.
CONTACT Linda Rath, RN 216-844-7028
TITLE N0147: A Randomized Phase III Trial of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU) Leucovorin (CF) after Curative Resection for Patients with Stage III Colon Cancer
DESCRIPTION This study will compare the overall survival of patients with Stage III colon cancer randomized to 24 weeks of adjuvant chemotherapy. Patients will be randomized to one of three arms. Patients in Arm A will receive 5-Fluorouracil, Leucovorin and Oxaliplatin for 24 weeks. Patients in Arm B will receive 5-Fluorouracil, Leucovorin and Irinotecan for 24 weeks. Patients in Arm C will receive 5-Fluorouracil, Leucovorin and Oxaliplatin for 12 weeks followed by 5-Fluorouracil, Leucovorin and Irinotecan for 12 weeks.
ELIGIBILITY
  1. Patients must have histologically documented adenocarcinoma of the colon.
  2. Patients must be randomized no more than 56 days post surgery.
  3. Patients with one or more synchronous primary colon cancer(s) are eligible.
  4. Patients must not have received prior chemotherapy or radiation therapy for treatment of this malignancy.
  5. Patients must have normal bone marrow, liver and kidney function.
CONTACT Linda Rath, RN 216-844-7028
TITLE E 8200: A Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, with Randomization Between Irinotecan/Docetaxel and Irinotecan/docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)
DESCRIPTION This study will determine the efficacy of the combination of irinotecan/docetaxel in patients with metastatic pancreatic cancer. Patients will be randomized to one of two arms. All patients will receive enoxaparin sodium every day from the start of treatment until treatment ends. Patients in Arm A will receive docetaxel and irinotecan once a week for 4 weeks. Patients in Arm B will receive C225 once a week for 6 weeks plus docetaxel and irinotecan once a week for 4 weeks. Patients will be evaluated after 2 cycles. The total number of cycles is determined by patient response. 
ELIGIBILITY
  1.  Patients must have histologically confirmed adenocarcinoma of the pancreas that is metastatic.
  2. Patients must not have had prior chemotherapy.
  3. Patients must have core or open biopsy material available for EGF-r testing.
  4. Patients must have primary of metastatic lesion measurable n at least one dimension within 4 weeks prior to randomization.
  5. Patients must have adequate bone marrow, liver, kidney and cardiac function.
CONTACT Linda Rath, RN 216-844-7028
TITLE BRMY 1203: A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients with Metastatic, EGFR-Positive Colorectal Carcinoma
DESCRIPTION This study will determine whether overall survival is prolonged in patients with metastatic epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluouropyrimidine/Oxaliplatin-based, non-irinotecan containing regimen. Patients will be randomized to one of two arms. Patients in Arm A will receive Cetuximab weekly and irinotecan every 3 weeks. Patients in Arm B will receive irinotecan every 3 weeks. The duration of treatment will be based on tumor reassessment done every six weeks.
ELIGIBILITY
  1. Patients must have histologically documented colorectal cancer which is EGFR-positive by IHC and is metastatic. 
  2. Patients must have received prior fluouropyrimidine- containing regimen for the first-line treatment of metastatic disease.
  3. Patients must have failed an Oxaliplatin-regimen for metastatic disease. Failure is defined as either progression of disease (clinical or radiologic) or intolerance to the Oxaliplatin regimen.
  4. Patients must have adequate recovery from recent surgery; chemotherapy and radiation therapy and at least 8 days must have elapsed.
  5. Patients must have adequate bone marrow, liver and kidney function.
CONTACT Linda Rath, RN 216-844-7028
TITLE CASE 1203: Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
DESCRIPTION This study will assess the total response rate of the Oxaliplatin, irinotecan and Capecitabine drug combination in advanced gastric/esophageal junction carcinoma. Patients will receive Oxaliplatin and Irinotecan weekly for 4 weeks plus Capecitabine twice a day for 4 weeks. Once cycle of treatment consists of 4 weeks of treatment followed by a 2-week rest. Patients will continue on treatment until disease progression or until unacceptable toxicity occurs.
ELIGIBILITY
  1. Patients must have histologically or cytologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. Patients must have metastatic or inoperable locally advanced disease.
  2. Patients must not have received prior chemotherapy for metastatic or recurrent disease. One course of neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiation therapy as primary treatment is acceptable.
  3. At least 4 weeks must have elapsed since prior radiation therapy and patients must have been off previous anti-cancer therapy for at least 4 weeks.
  4. Patients must not have a known hypersensitivity to 5-fluorouracil or history of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin, irinotecan and Capecitabine.
  5. Patients must have adequate bone marrow, liver and kidney function.
CONTACT Linda Rath, RN 216-844-7028
TITLE GVI 1202: A Randomized, Phase II Study of TNFerade Biologic with 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
DESCRIPTION This study is being done to assess the safety and potential activity of TNFerade biologic in patients randomized to chemoradiation with and without direct intratumoral injection of TNFerade biologic. Patients will be injected with TNFerade biologic once a week for five weeks (weeks 1-5). Radiation and chemotherapy with 5-FU will start on day 1 and continue concomitantly with TNFerade biologic for 5.5 weeks.
ELIGIBILITY
  1. Patients must have biopsy proven locally advanced adenocarcinoma of the pancreas assessed to be unresectable.
  2. Patients must not have received previous treatment for pancreatic cancer.
  3. Patients must have a life expectancy of greater than 3 months.
  4. Patients must not have metastatic disease.
  5. Patients must have normal bone marrow, liver and kidney function.
CONTACT Beth Bednarchik, RN 216-844-7314
TITLE Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)
DESCRIPTION This study will ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer survivals compared to the patients randomized to the Placebo Arm. Patients will be randomized to receive oral daily dose of STI571 or matching placebo for one year. Therapy must be initiated prior to 84 days from surgery. A patient receiving placebo may crossover to STI571 upon tumor recurrence.
ELIGIBILITY
  1. Patients must have a histologic diagnosis of primary GIST that expresses Kit protein by immunohistochemistry and have tumor size of greater than or equal to 3 cm in maximum dimension.
  2. Patients must be at least 18 years of age.
  3. Patients must have undergone complete gross resection of a primary GIST within 70 days prior to registration.
  4. Patients must have adequate bone marrow, kidney and liver function.
CONTACT Linda Rath, RN 216-844-7028
TITLE CALGB 80101: Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastrointestinal Adenocarcinoma
DESCRIPTION This study will determine whether overall survival is prolonged in patients with resected gastric adenocarcinoma who receive epirubicin, cisplatin, and infusional 5-FU (ECF) before and after infusional 5-FU plus radiotherapy (RT) when compared to those treated with bolus 5-FU and Leucovorin before and after infusional 5-FU plus RT.  Patients will be randomized to one of two arms.  Patients in Arm A will receive 5-FU and Leucovorin intravenously on days 1 through 5 of each 28-day cycle.  Patients in Arm B will receive Epirubicin and cisplatin on day 1 of each cycle and 5-FU on days 1 through 21 of each cycle.  Patients in both arms will receive 5-FU beginning on day one of RT and continuing until RT is completed. 
ELIGIBILITY
  1. Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction.

  2. Patients must not have received any previous chemotherapy or radiotherapy.

  3. Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical weight.

  4. Patients must be evaluated by a radiation oncologist prior to enrollment to ensure that the patient is an appropriate candidate for radiation therapy.

  5. Patients must have adequate cardiac function.

  6. Patients must have adequate bone marrow, liver and renal function.

CONTACT Linda Rath, RN 216-844-7028
 

Top

  Home | Cancer Information | Care Teams | Clinical Trials | Research Programs

11100 Euclid Avenue Cleveland, OH 44106
1-800-641-2422