Clinical trial · Interventional
Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial is studying the side effects and best dose of cixutumumab given together with doxorubicin hydrochloride and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together with doxorubicin hydrochloride may kill more tumor cells.
Conditions
Conditions (35)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Angiosarcoma | Adult Angiosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Desmoplastic Small Round Cell Tumor | Adult Desmoplastic Small Round Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Adult Epithelioid Sarcoma | Adult Epithelioid Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Extraskeletal Myxoid Chondrosarcoma | Adult Extraskeletal Myxoid Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Extraskeletal Osteosarcoma | Adult Extraskeletal Osteosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Fibrosarcoma | Adult Fibrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Leiomyosarcoma | Adult Leiomyosarcoma | ONTOLOGY_EXACT |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cixutumumab | Biological | Cixutumumab | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cixutumumab and doxorubicin hydrochloride)
- description
- Patients receive cixutumumab 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.
- interventionNames
- Biological: Cixutumumab
- Drug: Doxorubicin Hydrochloride
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- 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
- timeFrame
- Up to 2 courses of treatment
- description
- The MTD is defined as the dose of Cixitumumab that induces dose-limiting toxicity (DLT) in no more than 20% of patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChugh R, Griffith KA, Davis EJ, Thomas DG, Zavala JD, Metko G, Brockstein B, Undevia SD, Stadler WM, Schuetze SM. Doxorubicin plus the IGF-1R antibody cixutumumab in soft tissue sarcoma: a phase I study using the TITE-CRM model. Ann Oncol. 2015 Jul;26(7):1459-64. doi: 10.1093/annonc/mdv171. Epub 2015 Apr 9. PMID 25858498