Clinical trial · Interventional
Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
NCT00054119CI-TRIAL-00028615completedPhase 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 karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. 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 |
|---|---|---|---|
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cositecan | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cositecan
- Other: Pharmacological Study
Primary outcomes (6)
- measure
- Frequency of objective response
- timeFrame
- Up to 6 years
- measure
- Duration of objective response
- timeFrame
- Up to 6 years
- measure
- Frequency of observed adverse effects, graded according to CTC version 2.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * Platinum-resistant disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target) * Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 1.5 times ULN * No myocardial infarction within the past 6 months * No cerebrovascular accident within the past 6 months * No transient ischemic attack within the past 6 months * No uncontrolled hypertension * No decompensated or uncontrolled chronic heart failure * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No neuropathy (sensory or motor) grade 2 or greater * No other invasive malignancies within the past 5 years except nonmelanoma skin cancer * No active infection requiring antibiotics * At least 3 weeks since prior biological or immunological agents * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered * No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen * No prior karenitecin or camptothecin analogue/derivative * At least 1 week since prior hormonal therapy * Concurrent hormone replacement therapy allowed * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of marrow-bearing areas * Recovered from recent surgery * At least 3 weeks since prior therapy directed at this malignancy * No prior anticancer therapy that would preclude study therapy * No concurrent amifostine or other protective reagents
References
Publications (0)
Data not yet available
No reference posted for this study.