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A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma


Phase 1
16 Years
N/A
Open (Enrolling)
Both
Adult Angiosarcoma, Adult Desmoplastic Small Round Cell Tumor, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma of Bone, Adult Malignant Hemangiopericytoma, Adult Malignant Mesenchymoma, Adult Neurofibrosarcoma, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Childhood Angiosarcoma, Childhood Desmoplastic Small Round Cell Tumor, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Hemangiopericytoma, Childhood Malignant Mesenchymoma, Childhood Neurofibrosarcoma, Childhood Synovial Sarcoma, Dermatofibrosarcoma Protuberans, Metastatic Childhood Soft Tissue Sarcoma, Mixed Childhood Rhabdomyosarcoma, Pleomorphic Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

Thank you

Trial Information

A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma


PRIMARY OBJECTIVES:

I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine
if they can be combined with acceptable toxicity at full doses.

SECONDARY OBJECTIVES:

I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with
locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin
and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients
treated with doxorubicin and Cixitumumab.

III. To assess the progression free survival and overall survival of patients treated with
doxorubicin and Cixitumumab.

IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2,
4 and 6 cycles of therapy compared to baseline.

OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal
antibody cixutumumab.

Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15 and
doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease may continue to receive
cixutumumab in the absence of disease progression or unacceptable toxicity.


Inclusion Criteria:



- Histologically or cytologically confirmed soft tissue sarcoma

- Unresectable disease

- Locally advanced or metastatic disease

- The following tumor types are not allowed:

- Embryonal and alveolar rhabdomyosarcoma

- Gastrointestinal stromal tumor

- Alveolar soft part sarcoma

- Clear cell sarcoma

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- No more than 1 prior therapy for sarcoma

- No known brain metastases

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- ANC ≥ 1,500/µL

- Platelet count ≥ 100,000/µL

- Leukocytes ≥ 3,000/µL

- Total bilirubin ≤ upper limit of normal(ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- Fasting serum glucose < 120 mg/dL OR below ULN

- LVEF ≥ 50% by MUGA scan

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after the
last dose of anti-IGF-1R recombinant monoclonal antibody IMC-A12

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12

- No poorly controlled diabetes mellitus

- Patients with a history of diabetes mellitus are eligible provided their blood
glucose is within normal range and they are on a stable dietary or therapeutic
regimen for this condition

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would preclude compliance with
study requirements

- No other concurrent investigational or commercial agents or therapies

- Recovered from all prior therapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

- More than 4 weeks since prior major surgery, hormonal therapy (other than
replacement), or hormonal therapy

- No prior radiotherapy to the heart, mediastinum, or chest wall

- No prior anthracycline therapy or anti-IGF-1R therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximally tolerated dose (MTD) of cixitumumab when administered in a combination regimen with fixed dose doxorubicin hydrochloride, in patients with locally advanced or metastatic soft tissue sarcoma

Outcome Description:

The MTD is defined as the dose of Cixitumumab that induces dose-limiting toxicity (DLT) in no more than 20% of patients.

Outcome Time Frame:

Up to 2 courses of treatment

Safety Issue:

Yes

Principal Investigator

Rashmi Chugh

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00285

NCT ID:

NCT00720174

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Adult Angiosarcoma
  • Adult Desmoplastic Small Round Cell Tumor
  • Adult Epithelioid Sarcoma
  • Adult Extraskeletal Chondrosarcoma
  • Adult Extraskeletal Osteosarcoma
  • Adult Fibrosarcoma
  • Adult Leiomyosarcoma
  • Adult Liposarcoma
  • Adult Malignant Fibrous Histiocytoma of Bone
  • Adult Malignant Hemangiopericytoma
  • Adult Malignant Mesenchymoma
  • Adult Neurofibrosarcoma
  • Adult Rhabdomyosarcoma
  • Adult Synovial Sarcoma
  • Childhood Angiosarcoma
  • Childhood Desmoplastic Small Round Cell Tumor
  • Childhood Epithelioid Sarcoma
  • Childhood Fibrosarcoma
  • Childhood Leiomyosarcoma
  • Childhood Liposarcoma
  • Childhood Malignant Hemangiopericytoma
  • Childhood Malignant Mesenchymoma
  • Childhood Neurofibrosarcoma
  • Childhood Synovial Sarcoma
  • Dermatofibrosarcoma Protuberans
  • Metastatic Childhood Soft Tissue Sarcoma
  • Mixed Childhood Rhabdomyosarcoma
  • Pleomorphic Childhood Rhabdomyosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Previously Untreated Childhood Rhabdomyosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Histiocytoma
  • Chondrosarcoma
  • Fibrosarcoma
  • Hemangiopericytoma
  • Hemangiosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Mesenchymoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Synovial
  • Sarcoma
  • Histiocytoma, Benign Fibrous
  • Dermatofibrosarcoma
  • Neurofibrosarcoma
  • Neurilemmoma
  • Rhabdomyosarcoma, Embryonal
  • Desmoplastic Small Round Cell Tumor
  • Histiocytoma, Malignant Fibrous
  • Liver Neoplasms

Name

Location

Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Decatur Memorial HospitalDecatur, Illinois  62526
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
University of Michigan University HospitalAnn Arbor, Michigan  48109