Clinical trial · Interventional
Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma
Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]
- 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)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| pharmacokinetic study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days
- description
- Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.
Secondary outcomes (3)
- measure
- Time to Progression
- timeFrame
- post-cycle 2, 4, 8 and 12
- description
- Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed\* diagnosis of 1 of the following:
* Recurrent high-grade osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma
* Progressive disease after standard therapy
* Received no more than 2 additional salvage regimens
* Chondrosarcoma
* Unresectable OR locally recurrent and unable to be completely resected NOTE: \*Biopsy required for isolated pulmonary recurrences
* Measurable disease
* At least 1 unidimensionally measurable lesion by medical imaging techniques
* Ascites, pleural effusions, and bone marrow disease are not considered measurable disease
PATIENT CHARACTERISTICS:
Age
* 4 and over
Performance status
* ECOG (Eastern Cooperative Oncology Group) 0-2 (≥ 18 years of age)
* Karnofsky 50-100% (11-17 years of age)
* Lansky 50-100% (≤ 10 years of age)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
Hepatic
* Bilirubin ≤ upper limit of normal (ULN) (except for patients with Gilbert's syndrome)
* ALT ≤ 2.5 times ULN
Renal
* Creatinine clearance or radioisotope glomerular filtration rate \> 70 mL/min/1.73 m\^2 OR
* Serum creatinine ≤ ULN for age:
* Ages 5 and under ≤ 0.8 mg/dL
* Ages 6 to 10 ≤ 1.0 mg/dL
* Ages 11 to 15 ≤ 1.2 mg/dL
* Ages 16 to 18 ≤ 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* Sensory or motor neuropathy due to prior chemotherapy ≤ grade 1
* Sensory or motor neuropathy due to prior surgery or tumor involvement ≤ grade 2 AND stable or improving
* No active or uncontrolled infection
* No known hypersensitivity reaction to docetaxel or other polysorbate 80-formulated agents
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 72 hours since prior filgrastim (G-CSF)
* No prior allogeneic transplantation
* No concurrent immunotherapy
Chemotherapy
* At least 2 weeks since prior myelosuppressive therapy
* At least 6 months since prior myeloablative therapy
* No prior gemcitabine
* No prior taxanes
* No other concurrent chemotherapy
Endocrine therapy
* Concurrent hormonal therapy allowed
Radiotherapy
* At least 6 weeks since prior local radiotherapy
* At least 4 months since prior extensive radiotherapy to more than 50% of the pelvis
* At least 4 months since prior cranial spinal radiotherapy
* At least 6 months since prior total body irradiation
* No concurrent radiotherapy
Surgery
* No concurrent surgery
Other
* Recovered from all prior therapy
* No other concurrent investigational anticancer therapyReferences
Publications (2)
- BACKGROUNDKilgour-Christie J, Czarnecki A: Pulmonary adverse drug reactions in patients treated with gemcitabine and a combination of gemcitabine and a taxane. [Abstract] J Clin Oncol 23 (Suppl 16): A-8274, 796s, 2005.
- DERIVEDFox E, Patel S, Wathen JK, Schuetze S, Chawla S, Harmon D, Reinke D, Chugh R, Benjamin RS, Helman LJ. Phase II study of sequential gemcitabine followed by docetaxel for recurrent Ewing sarcoma, osteosarcoma, or unresectable or locally recurrent chondrosarcoma: results of Sarcoma Alliance for Research Through Collaboration Study 003. Oncologist. 2012;17(3):321. doi: 10.1634/theoncologist.2010-0265. Epub 2012 Feb 23. PMID 22363068