Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Calcium

Calcium, Dietary

Tubulin Modulators

Antimitotic Agents

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

paclitaxel

oxaliplatin

leucovorin

5-fluorouracil

glutathione

calcium and magnesium

Chemotherapy

Chemoprotection

Complementary and alternative therapy

Ben Chue, MD

Nick Chen, MD

Jerry Kaufman

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.

PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.

OBJECTIVES:

* The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in

  * Pain control and other aspects of quality of life
  * Reduction of the tumor size or stabilization of tumor growth
  * Progression free survival
  * Overall survival
* The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects

DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin

DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.

EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006.

QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer

Seattle Cancer Treatment and Wellness Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Capecitabine

Taxane

larotaxel

oral, twice daily, Day 1-Day 14 of a 21-day cycle

capecitabine

The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.

Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer

A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy

Sanofi

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Amino Acids

Tamoxifen

Tyrosine Kinase Inhibitors

Gefitinib

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ZD1839

tamoxifen

Uwe Wagner, Prof.Dr.

Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New therapeutic strategies are required in platinum-refractory disease. Inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established antiestrogen tamoxifen.

A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy

AGO Study Group

Peritoneal Neoplasms

Abdominal Neoplasms

Peritoneal Diseases

Gastrointestinal Agents

Antibodies

Antibodies, Bispecific

Immunoglobulins

Muromonab-CD3

Catumaxomab

anti-EpCAM x anti-CD3 (removab)

Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer, fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach.

Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer	NCT00323583	Adenocarincoma ... Stage III Pancr... Stage IVA Pancr... Stage IVB Pancr...	paclitaxel oxaliplatin leucovorin 5-fluorouracil glutathione calcium and mag... Chemotherapy Chemoprotection Complementary a...	18 Years - 65 Years	Seattle Cancer Treatment and Wellness Center
Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer	NCT00327743	Breast Cancer Cancer	larotaxel capecitabine	18 Years -	Sanofi
A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy	NCT00189358	Ovarian Cancer Cancer of the F... Peritoneal Canc...	ZD1839 tamoxifen	18 Years -	AGO Study Group
Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer	NCT00327743	Breast Cancer Cancer	larotaxel capecitabine	18 Years -	Sanofi
Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients	NCT00189345	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...	anti-EpCAM x an...	18 Years -	AGO Study Group

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