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Oxaliplatin

Liver Extracts

Cola

oxaliplatin

management of therapy complications

Christine Rebischung

Mohamed Hebbar, MD

Gerard Lledo

Olivier Rosmorduc, MD, PhD

Jean-Baptiste Meric, MD

Thierry Andre, MD

Philippe Lechat

RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.

PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

OBJECTIVES:

Primary

* Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.

Secondary

* Determine the pharmacokinetics of oxaliplatin in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.

Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin

GERCOR - Multidisciplinary Oncology Cooperative Group

Gallbladder Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Gemcitabine

Capecitabine

Antimetabolites

Adjuvant Chemotherapy

* Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle
* Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle

Chemoradiotherapy

-Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT

Radiation (RT):

3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.

intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

Adjuvant chemotherapy: 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle

Chemoradiotherapy: 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT

capecitabine

1000 mg/m\^2, IV, Days 1 \& 8 of each cycle

gemcitabine hydrochloride

4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.

3-dimensional conformal radiation therapy

4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

intensity-modulated radiation therapy

Edgar Ben-Josef, MD

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.

OBJECTIVES:

* To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy. (R0 stratum closed as of 12-15-11)
* To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival of patients treated with this regimen.
* To assess the frequency and severity of toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative \[R0\] vs microscopically positive \[R1\]). (R0 stratum closed as of 12-15-11)

* Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy patients are followed periodically for up to 5 years.

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.

Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).

National Cancer Institute (NCI)

SWOG Cancer Research Network

Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Adjuvant Chemotherapy:

Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.

Chemoradiotherapy:

Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

Adjuvant Chemotherapy + Chemoradiotherapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Negative (R0)

Microscopically positive (R1)

Margin of Resection

All eligible and analyzable patients that received protocol treatment.

SWOG Statistician

Eligible and analyzable patients that received a resection with negative (R0) margins.

Patients With Negative Margins of Resection (R0)

Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.

Patients w/Microscopically Positive Margin of Resection (R1)

Eligible and analyzable patients that received protocol treatment.

Stratum-specific (R0 and R1) 2-year Overall Survival

Anorexia

Cardiac troponin I (cTnI)

Constipation

Dehydration

Diarrhea

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Hemoglobin

Hemorrhage, GI - Duodenum

Hemorrhage, GI - Lower GI NOS

Hypotension

Lung Infection w/normal ANC or Gr 1-2 neutrophils

Skin Infection w/normal ANC or Gr 1-2 neutrophils

Infection-Other (Specify)

Leukocytes (total WBC)

Lymphopenia

Mucositis/stomatitis (clinical exam) - Oral cavity

Neuropathy: sensory

Neutrophils/granulocytes (ANC/AGC)

Phosphate, serum-low (hypophosphatemia)

Platelets

Potassium, serum-low (hypokalemia)

Rash/desquamation

Rash: hand-foot skin reaction

Sodium, serum-low (hyponatremia)

Syncope (fainting)

Thrombosis/embolism (vascular access-related)

Thrombosis/thrombus/embolism

Ulcer, GI - Duodenum

Ventricular arrhythmia - Ventricular tachycardia

Eligible patients who received any treatment and were assessed for adverse events are included in this summary.

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

2-year Overall Survival for All Patients

2-year Stratum-specific Disease-free Survival

2-year Disease-free Survival in All Patients

2-year Stratum-specific Local Relapse Rate

2-year Overall Local Relapse Rate

Overall Study

Dermatologic Agents

Central Nervous System Depressants

Dihematoporphyrin Ether

Trioxsalen

Ether

Photosensitizing Agents

Photodynamic Therapy plus biliary stenting

porfimer sodium

biliary stenting

Stephen P. Pereira, MD

RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.

PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.

OBJECTIVES:

Primary

* To assess the efficacy, in terms of overall survival, of biliary stenting with vs without photodynamic therapy using porfimer sodium in advanced, recurrent, or metastatic biliary tract carcinoma.

Secondary

* To evaluate the two treatments arms with respect to progression-free survival, toxicity using NCI Common Toxicity Criteria (version 3.0), and quality of life.

OUTLINE: This is a multicenter study. Patients are stratified by participating center, primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic), prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score (0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to 1 of 2 arms.

* Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of unilateral or bilateral plastic endoprostheses above the main strictures of the right and left hepatic bile ducts.
* Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium IV and then undergo laser activation 48 hours later.

After completion of study treatment, patients are followed every 3 months for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery

Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study

University College, London

Cisplatin

25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins

cisplatin

1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.

John A. Bridgewater

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.

OBJECTIVES:

Primary

* Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.

Secondary

* Compare the progression-free survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy \[PDT\] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.

After completion of study treatment, patients are followed periodically for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors

Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study

From date of randomisation till date of death or last date of follow-up (up to 5 years)

Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically

Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.

Eli Lilly and Company

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer	NCT00274885	Cancer	oxaliplatin management of t...	18 Years -	National Cancer Institute (NCI)
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct	NCT00789958	Extrahepatic Bi... Gallbladder Can...	capecitabine gemcitabine hyd... 3-dimensional c... intensity-modul...	18 Years - 120 Years	SWOG Cancer Research Network
Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery	NCT00513539	Extrahepatic Bi... Gallbladder Can...	porfimer sodium biliary stentin...	18 Years -	University College, London
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors	NCT00262769	Extrahepatic Bi... Gallbladder Can...	cisplatin gemcitabine hyd...	16 Years -	University College, London
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct	NCT00789958	Extrahepatic Bi... Gallbladder Can...	capecitabine gemcitabine hyd... 3-dimensional c... intensity-modul...	18 Years - 120 Years	SWOG Cancer Research Network

Spots Global Cancer Trial Database for metastatic gallbladder cancer