Clinical trial · Interventional
Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer
NCT00020696CI-TRIAL-00006029completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| tirapazamine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Platinum-sensitive disease * Treatment-free interval of more than 6 months without clinical evidence of progressive disease after a response to a platinum compound * One prior chemotherapy regimen containing cisplatin or another platinum compound for primary disease required * Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients not previously treated with paclitaxel may receive a second regimen containing paclitaxel * No additional cytotoxic chemotherapy (including retreatment with initial regimens) for recurrent or persistent disease * Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for the same patient population) * Treatment-free interval of more than 12 months if non-platinum-based GOG-0146 series protocol is active concurrently with this protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No prior or concurrent myocardial infarction or ischemic heart disease Other: * No active infection requiring antibiotics * No sensory or motor neuropathy greater than grade 1 * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunological agents directed at malignant tumor Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy * No prior tirapazamine Endocrine therapy: * At least 1 week since prior hormonal therapy directed at malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy: * Recovered from prior radiotherapy * No prior radiotherapy to site(s) of measurable disease used on this study * No prior radiotherapy to more than 25% of bone marrow Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No prior cancer treatment that would preclude study * At least 3 weeks since other prior therapy directed at malignant tumor
References
Publications (1)
- RESULTCovens A, Blessing J, Bender D, Mannel R, Morgan M; Gynecologic Oncology Group. A phase II evaluation of tirapazamine plus cisplatin in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Mar;100(3):586-90. doi: 10.1016/j.ygyno.2005.09.032. Epub 2005 Oct 24. PMID 16249022