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TumorsPhase 1NCT01031212

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

A Phase 1 study testing ASA404, Cetuximab and Carboplatin in people with Tumors, run by University of California, San Francisco at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors
What is being tested?
ASA404, Cetuximab and Carboplatin
Type of treatment
Injection or infusion
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2010to Jun 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmed malignancy of advanced, incurable solid tumor
  • Progression following standard therapy, or no acceptable standard treatment options, or eligible if standard therapy consists of a platinum-based doublet
  • Measurable or evaluable disease. Measurable disease required for enrollment in dose expansion cohort at MTD
  • ECOG 0-2
  • Baseline neuropathy grade ≤ 1
  • leukocytes >3,000/mcL
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  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <1.5 X institutional ULN
  • creatinine within 1.5 x normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2
  • Ability to give written informed consent and willingness to comply with requirements of the protocol
  • Women of child-bearing potential must have a negative pregnancy test within 14 days of beginning study drug and agree to use an effective method of birth control during treatment and for six months after last dose of study drug
  • Male patients whose sexual partners are women of reproductive potential must be surgically sterile or agree to use a double method of contraception during the study and for six months after last dose of study drug. One of method must be a condom
  • Patients with known brain metastases should have "stable disease" defined as no growth over a 6 week period after definitive therapy (surgical or RT), and off steroids and anticonvulsive therapy

Who cannot join

  • Chemotherapy, hormonal therapy or biologic therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the start of study therapy or not recovered to < grade 2 from adverse events due to prior agents
  • Prior therapy with EGFR inhibitors is permitted
  • Patients receiving palliative radiation therapy <2 weeks earlier. Patients must have recovered from all toxicities of radiation
  • Receiving any other investigational agents
  • Any severe and/or uncontrolled intercurrent medical conditions or other conditions that could affect participation in the study
  • Any of the following cardiac abnormalities: unstable angina pectoris, including Prinzmetal variant angina, New York Heart Association (NYHA) Classification for Congestive Heart Failure Grade III or greater, myocardial infarction or stroke ≤ 12 months prior to study treatment, long QT syndrome, baseline 12 lead ECG QTc of >450msec per central evaluation, history of sustained ventricular tachycardia, history of ventricular fibrillation or Torsades de Pointes, right bundle branch block and left anterior hemiblock (bifascicular block), bradycardia (<50 beats per minute)
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  • Concomitant use of drugs with a risk of causing Torsades de Pointes
  • PT/PTT > 1.5 x ULN
  • Receiving full-dose anticoagulation (low-dose warfarin for a central line allowed)
  • History of another primary malignancy less than 5 years prior, except non-melanoma skin cancer or cervical cancer in-situ
  • Major surgery ≤ 4 weeks prior (requiring general anesthesia or respiratory assistance)(endoscopic exams with diagnostic intent allowed)
  • Minor surgery ≤ 2 weeks prior (not requiring general anesthesia or respiratory assistance)
  • Insertion of vascular access device allowed
  • Not recovered from surgery-related complications
  • Systolic BP >160mmHg and/or diastolic BP >90mmHg while on medication for hypertension
  • Hemoptysis associated with chest malignancy <4 weeks (>1 teaspoon)
  • History of hypersensitivity reactions to TAXOL or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil)
  • History of severe allergic reactions to cisplatin or other platinum-containing compounds
  • History of acute hemorrhagic events requiring hospital admission or blood transfusion
  • Pregnant or lactating women
  • Fertile women and men not willing to comply with birth control instructions
  • Any condition that compromises compliance with objectives and procedures of this protocol, as judged by the principal investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase I Study of ASA 404 in Combination With Carboplatin/Paclitaxel/Cetuximab in Patients With Refractory Solid Tumors

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.

Read the detailed description

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.

Conditions
Tumors
Being tested
ASA404, Cetuximab, Carboplatin, Paclitaxel
Keywords
cancer, neoplasms, adult solid tumor, antineoplastic agents
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASA404Drug

    Also called 5-6-dimethylxanthenone-4-acetic acid, DMXAA, AS1404

    Administered intravenously over 20 minutes weekly after chemotherapy

  • CetuximabDrug

    Also called Erbitux

    Administered at 400mg/m2 over 120 minutes on day -7 and then 250mg/m2 over 60 minutes weekly thereafter

  • CarboplatinDrug

    Also called Paraplatin

    Administered at fixed dose of AUC 6 intravenously on day 1 of each 3-week cycle

  • PaclitaxelDrug

    Also called Taxol

    Administered over 3 hours at a fixed dose of 175mg/m2 intravenously on day 1 of each 3-week cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    Measured: During cycle 1 (4 weeks)

Secondary outcomes (5)

  1. The number and percentage of subjects experiencing one or more AEs will be summarized by dose cohort, relationship to study drug, and severity

    Measured: Within 30 days after study treatment, or until resolution of AE

  2. Pharmacokinetics of ASA404 in combination with other agents

    Measured: 48 hours after cycle 1, day 1

  3. Disease response by RECIST criteria

    Measured: until progression

  4. Assess biological correlates of antitumor activity by measuring serum 5HIAA, VEGF, bFGF, PLGF, sVEGFR2, FGF 23, serum apoptotic markers (M30/M65)

    Measured: 4 weeks after treatment end

  5. DNA analysis of FGFR1 and VEGF polymorphism

    Measured: 4 weeks after treatment ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2012 (estimated)
  4. Study completionJun 2013 (estimated)

Why it stopped: The investigator has left the institution (UCSF) prior to study start-up

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01031212
Sponsor's protocol ID
UCSF-09997
Other IDs
H53469-35218
Status last verified
May 2013
First submitted
8 Dec 2009
Last updated
13 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASA404, Cetuximab and Carboplatin in people with Tumors, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: During cycle 1 (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01031212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.

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