Clinical trial · Interventional
S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer
NCT00053833CI-TRIAL-00012613terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan
- description
- irinotecan
- interventionNames
- Drug: irinotecan
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
* No mixed mullerian and borderline ovarian tumors
* Surgically staged as stage III or IV at initial diagnosis
* Must meet one of the following criteria for refractory/relapsed disease:
* Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy
* Had a best response of increasing disease during this front-line regimen
* Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen
* Unidimensionally measurable disease
* At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
* At least 1 cm by spiral CT scan
* Measurable disease must remain outside of radiotherapy field
* If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No myocardial infarction within the past 6 months
* No angina pectoris
* No uncontrolled congestive heart failure
* No uncontrolled cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer from which the patient is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior biological response modifier
* At least 28 days since prior biological response modifier and recovered
Chemotherapy
* See Disease Characteristics
* No prior topotecan or other topoisomerase I inhibitor
* One other additional prior chemotherapy regimen allowed
* At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered
Endocrine therapy
* Prior hormonal therapy allowed
* No concurrent hormonal therapy
Radiotherapy
* At least 28 days since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of bone marrow
* No concurrent palliative radiotherapy
Surgery
* At least 14 days since prior major surgery and recovered
Other
* At least 28 days since prior investigational drugs and recovered
* No other concurrent antitumor therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.