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Thymic CancerPhase 2NCT00369889

A Study to Test the Safety and Efficacy of Erlotinib Plus Bevacizumab to Treat Advanced Thymoma and Thymic Cancer

A Phase 2 study testing bevacizumab and Erlotinib in people with Thymic Cancer and Thymoma, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the rate of response with the combination of erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma, and to determine potential molecular markers that may predict response to therapy in patients with thymoma or thymic carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymic Cancer, Thymoma
What is being tested?
bevacizumab and Erlotinib
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2006to Sep 2007
Phase
Phase 2
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

  • Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery in the opinion of the investigator. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
  • Patients must have measurable disease per RECIST. Note: Any scans or x-rays used to document measurable disease must be obtained within 28 days prior to registration.
  • Patients must have had prior chemotherapy (no limit for prior regimens) for metastatic disease.
  • Patients must not have had any form of systemic anticancer therapy within 21 days prior to being registered for protocol therapy.
  • Patients receiving radiation therapy must have completed their radiation at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration. Previously radiated area(s) must not be the only site of disease.
  • Be at least 18 years of age at the time of consent.
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  • Patient's must have laboratory data as specified below within 14 days of registration to study:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) (unless liver metastases are present, in which case AST/ALT ≤ 5 times upper limit of normal will be acceptable).
  • Total bilirubin ≤ 1.5 mg/dl.
  • White blood cell (WBC) count > 3000/mm3
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelets ≥ 100,000/mm3
  • International normalized ration (INR) of prothrombin time ≤ 1.2, and aPTT no more than 5 seconds longer than the ULN
  • Urine protein:creatinine ratio 1.0 at screening.
  • Patients must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.
  • No prior use of an EGFR inhibitor or anti-angiogenic agent.
  • No use of an investigational agent within 30 days prior to registration for study protocol.
  • Must not have any contraindications to the use of erlotinib or bevacizumab as per the package labeling for either product.
  • No uncontrolled hypertension ( e.g. > 150/100 mmHg pretreatment)
  • No history of unstable angina.
  • No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • No history of myocardial infarction or angina pectoris/ anginal equivalent in the last 6 months (the patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months )within 6 months prior to registration for protocol therapy.
  • No history of stroke within 6 months prior to registration for protocol therapy.
  • No clinically significant peripheral vascular disease.
  • No evidence of bleeding diathesis or coagulopathy.(Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed).
  • Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function daily within 10 days prior to registration..
  • Patients may not be taking the following drugs known to inhibit platelet function: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
  • No known evidence of central nervous system involvement or brain metastases. If symptomatic must be confirmed by Head CT or Brain MRI within 6 weeks prior to being registered for protocol therapy.
  • No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
  • No anticipation of need for major surgical procedure during the course of the study.
  • No minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
  • No serious, non-healing wound, ulcer, or bone fracture.
  • No history of hemoptysis.
  • No history of deep vein thrombosis or pulmonary embolism.
  • No active infections.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Phase II Study of Erlotinib Plus Bevacizumab in the Treatment of Advanced Thymoma and Thymic Carcinoma

The purpose of this study is to determine the rate of response with the combination of erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma, and to determine potential molecular markers that may predict response to therapy in patients with thymoma or thymic carcinoma.

Read the detailed description

We believe that both the EGFR pathway, as well as tumor angiogenesis play an important role in the pathogenesis of thymic neoplasms. Our previous experience with the EGFR inhibitor gefitinib showed a promising, though limited activity in this disease. We hypothesize that combining the novel EGFR inhibitor erlotinib with bevacizumab will have a synergistic effect on this tumor. We have selected the 15mg/kg q21 days of bevacizumab based on the data published by Johnson DH et al, in which 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m2) every 3 weeks or carboplatin and paclitaxel alone (n = 32). The highest response noted in the high-dose group (31.5%) and 28.1% in the lower dose bevacizumab arm. There was also a trend to improved TTP and OS in the high dose arm, although the study lacked sufficient power to make any definitive conclusions regarding a possible relationship between dose and treatment effect. (105) The safety and efficacy of this dose and schedule was confirmed by E4599 (43). Herbst et al have confirmed the safety of the combination of erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg in a published phase I/II trial (74)

This regimen has the potential to provide a new, effective therapy for this malignancy, as well as teaching us important lessons about the biology of the disease. To this end, we would also measure surrogate markers of angiogenesis, such as tumor VEGF expression, serum VCAM-1 and bFGF, as well as urine VEGF. We would also determine tumor expression of phosphorylated EGFR, and analyze the effect of known variant polymorphisms in the VEGF gene on outcomes. We will test tumor samples for expression of EGFR by IHC and FISH to correlate to response.

Being tested
bevacizumab, Erlotinib
Keywords
Thymoma, Thymic Cancer
Medical subject headings
Thymus Neoplasms, Thymoma

What participants receive

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

What is being measured

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

  1. To determine the objective response rate of the combination of erlotinib and bevacizumab in using RECIST.

    Measured: completion of study

Secondary outcomes (6)

  1. To determine the time to progression of patients previously treated with thymoma and thymic carcinoma treated with the combination of erlotinib and bevacizumab.

    Measured: completion of study

  2. To determine the toxicity of the combination of erlotinib and bevacizumab in this patient population.

    Measured: completion of study

  3. To correlate expression of VEGF in primary tumor sample, circulating VCAM-1 and bFGF, urine VEGF levels pre-therapy with response to therapy.

    Measured: completion of study

  4. To assess for the effect of known (functionally accepted) variant polymorphisms in the VEGF gene on outcomes.

    Measured: completion of study

  5. To determine expression of phosphorylated EGFR receptor in tumor specimen

    Measured: completion of study

  6. To correlate expression of EGFR by IHC and FISH with response to therapy.

    Measured: completion of study

Timeline

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

  1. First posted30 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionSep 2007
  4. Study completionSep 2007

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369889
Sponsor's protocol ID
IUCRO-0148 / 0606-20
Other IDs
AVF3891s, IUCRO-0148
Status last verified
May 2014
First submitted
28 Aug 2006
Last updated
3 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and Erlotinib in people with Thymic Cancer and Thymoma, run by Indiana University 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 36 inclusion and 0 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: finished, as of the sponsor's last update on 3 Jun 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the objective response rate of the combination of erlotinib and bevacizumab in using RECIST. (time frame: completion of study). 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 NCT00369889.

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 3 Jun 2014.

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