Clinical trial · Interventional
Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma
Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma
NCT00003778CI-TRIAL-00009376completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dolastatin 10 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: dolastatin 10
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven recurrent or metastatic soft tissue sarcoma * No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field * Pulmonary nodule(s) at least 1 x 1 cm No brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0 or 1 * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 1.5 mg/dL * AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present) * Creatinine no greater than 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * No uncontrolled infection * No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen in the adjuvant setting * No prior chemotherapy for metastatic disease * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * At least 4 weeks since prior radiotherapy * Recovered from prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.