Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cetuximab

Antimetabolites

Antineoplastic Agents, Immunological

gemcitabine followed by cetuximab (sequential)

400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression

cetuximab

1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles

gemcitabine

1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles

400 mg/m2 first dose followed by 250 mg/m2 weekly

Cesare Gridelli, M.D.

Fortunato Ciardiello, M.D., Ph.D

Francesco Perrone, M.D., Ph.D

Ciro Gallo, M.D., Ph.D

The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.

The standard treatment for advanced non small cell lung cancer (NSCLC) is combination chemotherapy with cisplatin or carboplatin. Due to its toxicity, this therapy may not be suited for certain patients including the elderly, those whose general condition is poor. Combining chemotherapy with a biologic agent ("targeted therapy") is a new strategy being evaluated for the treatment of NSCLC, and cetuximab is one of the drugs that has shown promise for its activity and tolerability. This study aims to determine the more promising of 2 methods of combining gemcitabine with cetuximab (in combination vs. sequential administration), in two groups of patients who are not candidates for combination platinum based chemotherapy: patients under age 70 with performance status 2 (expected enrollment 42) , and patients over age 70 (expected enrollment 58).

Patients will be randomly assigned to one of two treatment arms:

* Arm A: Cetuximab + Gemcitabine:

  * Cetuximab given intravenously weekly AND
  * Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle)
* Arm B: Gemcitabine followed by Cetuximab:

  * Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle) THEN
  * Cetuximab given intravenously weekly

In Arm B, Cetuximab is administered as maintenance therapy when there has been an objective response to chemotherapy, or as second line therapy in patients who had disease progression during chemotherapy

CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer

Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.

National Cancer Institute, Naples

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

Capecitabine

Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy

XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy

50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.

XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.

XELOX

Binbin Cui, MD

Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge \< 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.

Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial

Harbin Medical University

Director of Abdominal Surgery Department

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

Dermatologic Agents

Anti-Infective Agents

Aminolevulinic Acid

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Photosensitizing Agents

Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light

Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation

Administered 4 weeks after completion of imiquimod therapy

Photodynamic therapy

Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

Michael Gold, MD

Joel Cohen, MD

Girish Munavalli, MD

The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone

Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.

Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.

Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.

Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.

This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.

Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

The percent change in actinic keratosis count as compared to the baseline lesion count

The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).

Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:

INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation

1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity

Graceway Pharmaceuticals, LLC

Tennessee Clinical Research Center

From study entry (Visit 1) to end of study (visit 5).

Imiquimod Followed by Photodynamic Therapy

Imiquimod Followed by Observation

Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.

Non-Randomized

Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Total facial actinic keratosis count

Early termination (slow enrollment) leading to small numbers of subjects analyzed; missing measurement(s) on a patient

Medical Director

Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.

Actinic Keratosis Count

Randomized patients with a week 18 actinic keratosis count.

Complete Clearance

Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.

Cosmetic Appearance

Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples
Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer	NCT02022852	Rectal Cancer	Capecitabine XELOX	18 Years -	Harbin Medical University
CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples
CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy	NCT01203878	Actinic Keratos...	Photodynamic th... Imiquimod	18 Years -	Tennessee Clinical Research Center

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