Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Lung Neoplasms

Recurrence

Head and Neck Neoplasms

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

Cetuximab

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All patients will receive cetuximab by IB weekly and daily doses of lapatinib orally in 3 week cycles with response assessed every 2 cycles.

Cetuximab: 400 mg/m2 on Day 1 then 250 mg/m2 weekly

Lapatinib: Start once daily on Day 1. Dose escalating cohorts:

1. 750 mg (3 tabs)
2. 1000 mg (4 tabs)
3. 1250 mg (5 tabs)

cetuximab and lapatinib

John F Deeken, M.D.

This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy.

Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time.

In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.

Lapatinib and Cetuximab in Patients With Solid Tumors

A Phase I Study of Lapatinib and Cetuximab in Patients With Solid Tumors

The dose at which \</= 1 out of 6 subjects experiences a dose limting toxicity

How well tumor responds to treatment as measured by RECIST criteria

Pharmacokinetics of lapatinib as measured by weekly trough levels

genetic polymorphisms in ABCG2, ABCB1, CYP3A4, and CYP3A5 wil be identified and counted

Genetic variations and activation status for EGFR amd ErbB2 pathways will be measured in pre- and post-therapy biopsies and assessed with western blots and IHC.

GlaxoSmithKline

Georgetown University

Disease Attributes

Micronutrients

Hematinics

Vitamins

Irinotecan

Raltitrexed

Topoisomerase I Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7).Radiation: 45-55Gy/25-30Fx

Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) per week. Radiation: 45-55Gy/25-30Fx

Radiotherapy Combined With Raltitrexed and Irinotecan

Zhen Zhang, MD

The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.

A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer

A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal Cancer

Fudan University

professor

Leucovorin

Fluorouracil

Levoleucovorin

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

AZD8931 160 mg bd, on days 1-4, + FOLFIRI in a 2 weekly schedule

160 mg AZD8931 tablets, twice daily on days 1 - 4 of each 2-weekly cycle

AZD8931

180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid.

350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan.

400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid.

2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.

Daniel Hochhauser, BA, MBBS, MRCP, D.PHIL, FRCP

Recruitment to phase I of the PANTHER trial is complete.

Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.

PANTHER is a registered phase I/phase II trial in patients with recurrent or metastatic colorectal cancer.

The phase II part of the study will be a single arm trial. Patients will receive AZD8931 (an EGFR/ERBB inhibitor) in combination with FOLinic acid, Fluorouracil and IRInotecan (FOLFIRI), Treatment will be given in two-weekly cycles. Phase II's primary objective is to evaluate the Best overall response

Phase I/II Trial of Antagonism of HER in GI Cancer

AZD8931, an Inhibitor of EGFR, ERBB2 and ERBB3 Signalling, in Combination With FOLFIRI: a Phase I/II Study to Determine the Importance of Schedule and Activity in Colorectal Cancer

Best overall response will be assessed according to RECIST v1.1.

Percentage change in tumour size will be considered the best response only if a second assessment has been carried out which confirms SD at least four weeks after trial entry. Assessment will be determined using CT scans performed at baseline, 12 weeks after start of chemotherapy, then every 3 months until disease progression up to 3 years from registration/ randomisation

Progression-free survival time will be calculated from the date of trial entry to the date of documented progression, or death from any cause. In cases where progression is suspected and subsequently confirmed by scans, the date of documented suspected progression will be used.

Overall survival time will be calculated from the date of trial entry to the date of death from any cause or end of trial follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lapatinib and Cetuximab in Patients With Solid Tumors	NCT01184482	Colorectal Canc... Lung Cancer Head and Neck C...	cetuximab and l...	18 Years -	Georgetown University
A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer	NCT04499586	Recurrent Color...	Radiotherapy Co...	18 Years - 75 Years	Fudan University
A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer	NCT04499586	Recurrent Color...	Radiotherapy Co...	18 Years - 75 Years	Fudan University
Phase I/II Trial of Antagonism of HER in GI Cancer	NCT01862003	Metastatic Colo... Recurrent Color...	AZD8931 Irinotecan Folinic Acid Fluorouracil Fluorouracil	16 Years -	University College, London

Spots Global Cancer Trial Database for recurrent colorectal cancer