ASA404 in Combination With Carboplatin/Paclitaxel/Cetuximab in Treating Patients With Refractory Solid Tumors

2014-08-27 03:17:19 | BioPortfolio


This phase I trial is studying the side effects and best dose of an investigational drug called DMXAA (5-6-dimethylxanthenone-4-acetic acid) or ASA404 when given together with carboplatin, paclitaxel and cetuximab to treat patients with refractory solid tumors.


Phase I 3+3 dose escalation design in patients with solid tumors who have been previously treated with chemotherapy or for whom no standard treatment options exist. Carboplatin, paclitaxel and cetuximab will be administered in standard doses. The dose of ASA404 will be escalated under predefined levels. One treatment cycle constitutes 3 weeks. A minimum of 3 patients will be entered at each treatment level, to be expanded to 6 subjects if dose limiting toxicities (DLT) are observed. If no more than one in six patients has DLT, additional patients will be enrolled at a higher dose. Once a maximum tolerated dose (MTD) has been established, the tolerability of this dose will be tested in a total of 12 patients. The anticipated sample size is 18-24 patients.

Carboplatin and paclitaxel are chosen as the chemotherapy back bone since they are commonly used in combination in multiple tumors. Cetuximab has been chosen as the EGFR inhibitor because the combination of platinum based therapy with cetuximab is effective in lung and head and neck cancers. In addition the safety and activity of carboplatin/paclitaxel with ASA 404 has already been demonstrated. A weekly schedule of ASA is chosen because 1) the safety of the weekly schedule has been tested 2) preclinical studies confirm enhanced activity with frequent administration 3) provides an opportunity to evaluate the safety and pharmacokinetics of ASA 404 with weekly cetuximab.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment




ASA404, Cetuximab, Carboplatin, Paclitaxel


UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
United States


Not yet recruiting


University of California, San Francisco

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:19-0400

Clinical Trials [2765 Associated Clinical Trials listed on BioPortfolio]

An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)

The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in combination with paclitaxel and Carboplatin are assessed. ASA404 is administered intravenously every ...

Paclitaxel/Carboplatin With or Without Cetuximab in CUP

The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma...

Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and p...

Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer

This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free su...

A Study in Advanced Solid Tumors

The primary purpose of this study is to help answer the following research question(s): - To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken ...

PubMed Articles [3382 Associated PubMed Articles listed on BioPortfolio]

Carboplatin/Paclitaxel Induction in Ovarian Cancer: The Finer Points.

The carboplatin/paclitaxel doublet remains the chemotherapy backbone for the initial treatment of ovarian cancer. This two-drug regimen, with carboplatin dosed using the Calvert formula, yielded convi...

Nanoparticle albumin bound-paclitaxel for treatment of advanced non-small cell lung cancer: an evaluation of the clinical evidence.

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor, has demonstrated clinical efficacy in the treatment of advanced non-small cell lung cancer (NSCLC) either as monotherap...

Complete Response of Metastatic Melanoma to Second Line Chemotherapy with Paclitaxel and Carboplatin - Case Report.

We present a patient with metastatic melanoma who had a complete response to second line chemotherapy with paclitaxel and carboplatin.

Brief Report on 3-Weekly Paclitaxel Carboplatin Efficacy in Locally Advanced or Metastatic Squamous Vulvar Cancer.

In this brief report, we present our experience with 3-weekly paclitaxel-carboplatin chemotherapy for patients with vulvar cancer. Two patients with locally advanced disease had an impressive response...

Concomitant administration of candesartan cilexetil in patients on paclitaxel and carboplatin combination therapy increases risk of severe neutropenia

Angiotensin receptor blockers (ARBs) are often used in patients on paclitaxel (PTX) and carboplatin combination (TC) therapy to treat hypertension caused by the co-administration of bevacizumab. The a...

Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

An organoplatinum compound that possesses antineoplastic activity.

A chimeric monoclonal antibody that functions as an ANTINEOPLASTIC AGENT through its binding to the EPIDERMAL GROWTH FACTOR RECEPTOR, where it prevents the binding and signaling action of cell growth and survival factors.

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).

More From BioPortfolio on "ASA404 in Combination With Carboplatin/Paclitaxel/Cetuximab in Treating Patients With Refractory Solid Tumors"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial