Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Bevacizumab

Capecitabine

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily

bevacizumab, erlotinib

bevacizumab 7.5 mg/kg body weight every third week

bevacizumab

bevacizumab 7.5 mg/kg body weight every third week.

low dose capecitabine

Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Hoffmann-La Roche

Lund University Hospital

Adenocarcinoma

Herbal and Botanical

Cola

bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity

bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity

Aimery de Gramont, MD

Christophe Tournigand, MD

PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

* Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.

Secondary

* Compare the duration of disease control and overall survival of patients treated with these regimens.
* Compare the tolerability of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the occurrence of secondary surgery in patients treated with these regimens.
* Compare the chemotherapy-free intervals and response rates in patients treated with these regimens.

INDUCTION THERAPY

Bevacizumab IV over 30-90 minutes on day 1, combined with either:

* modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil),
* XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8),
* FOLFIRI (IV : irinotecan, folinic acid, fluorouracil).

Treatment repeats every 2 weeks.

RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy with bevacizumab alone or bevacizumab+erlotinib

MAINTENANCE THERAPY

* Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1
* Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib once daily on days 1-21.

In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

ACCRUAL: A total of 700 patients will be accrued for this study.

Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)

Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2

GERCOR - Multidisciplinary Oncology Cooperative Group

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Recurrence

Disease Progression

Adenocarcinoma of Lung

Adenocarcinoma, Bronchiolo-Alveolar

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

* Bevacizumab 7.5 mg/kg i.v. every 3 weeks and
* Erlotinib 150 mg p.o. daily until progression.

Cohort 1:

Induction chemotherapy with

* Bevacizumab 7.5 mg/kg i.v. and
* Pemetrexed 500 mg/m2 i.v. and
* Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression.

Followed by maintenance therapy in patients without disease progression with

* Bevacizumab 7.5 mg/kg i.v. and
* Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.

Cohort 2:

Induction chemotherapy with

* Pemetrexed 500 mg/m2 i.v. and
* Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression.

Followed by maintenance therapy in patients without disease progression with

o Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.

Induction chemotherapy with

* Bevacizumab 7.5 mg/kg i.v. and
* Pemetrexed 500 mg/m2 i.v. and
* Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression. Followed by maintenance therapy in patients without disease progression with
* Bevacizumab 7.5 mg/kg i.v. and
* Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.

bevacizumab, pemetrexed, cisplatin

Oliver Gautschi, MD

Adrian Ochsenbein, MD

Nicolas Mach, MD

Sacha Rothschild, MD

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer.

PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

* To demonstrate that tailored therapy, according to tumor histology and EGFR-mutation status, and the introduction of novel drug combinations in the frontline treatment of patients with stage IV non-squamous non-small cell lung cancer, is promising for further investigation.

Secondary

* To prospectively explore molecular markers of clinical outcomes.

OUTLINE: This is a multicenter study. Patients are stratified according to EGFR(epidermal growth factor receptor)-mutation status (mutated vs wildtype). Patients are assigned to 1 of 2 groups.

* mutEGFR (mutated epidermal growth factor receptor) group: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
* wtEGFR (wildtype epidermal growth factor receptor) group cohort 1:

  * Induction chemotherapy: Patients receive bevacizumab IV over 30-90 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  * Maintenance therapy: Patients without progressive disease receive bevacizumab IV over 30-90 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression.

Blood and tissue specimens are collected for EGFR and molecular markers analysis, including gene expression, mutation, and pharmacogenomic analyses.

After completion of study treatment, patients are followed every 3 months.

* wtEGFR (wildtype epidermal growth factor receptor) group cohort 2:

  * Induction chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes, and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  * Maintenance therapy: Patients without progressive disease receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression.

Blood and tissue specimens are collected for EGFR and molecular markers analysis, including gene expression, mutation, and pharmacogenomic analyses.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 129 evaluable patients (77 in cohort 1 and 52 in cohort 2) with wtEGFR status and 20 patients with mutEGFR status will be accrued for this study.

Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Bevacizumab, Pemetrexed and Cisplatin, or Erlotinib and Bevacizumab for Advanced Non-Squamous NSCLC Stratified by EGFR Mutation Status. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Swiss Group for Clinical Cancer Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital
Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)	NCT00265824	Colorectal Canc...	bevacizumab bevacizumab, er...	18 Years - 80 Years	GERCOR - Multidisciplinary Oncology Cooperative Group
Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).	NCT01116219	Lung Cancer	bevacizumab, er... bevacizumab, pe...	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for bevacizumab, erlotinib