Clinical trial · Interventional
Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin
A Phase II Trial of Lapatinib in Combination With Weekly Topotecan in Patients With Platinum-Refractory/Resistant Ovarian and Primary Peritoneal Carcinoma
- 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: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with topotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin.
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 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib + Topotecan
- description
- Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
- interventionNames
- Drug: Lapatinib
- Drug: Topotecan
Primary outcomes (1)
- measure
- Response Rate (Complete Response (CR) or Partial Response (PR))
- timeFrame
- Two consecutive evaluations at least 4 weeks apart
- description
- Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter \>= 2cm with conventional techniques or \>=1cm with spiral CT * Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart. * Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions. Non-measurable disease patients: * Decrement in CA125 by \> 50% * Improvement in other evaluable disease
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
* Must have one of the following:
* Measurable disease
* Evaluable disease AND a CA-125 value that has increased ≥ 2 times the nadir value established after debulking surgery and first-line chemotherapy, confirmed by a second measurement within the past 21 days
* If a second measurement has not been done, it can be done ≥ 7 days but \< 21 days prior to study treatment
* Platinum-refractory and/or -resistant disease after first-line chemotherapy
* Patients retreated with platinum agents (i.e., second relapse) are not eligible
* Patients treated with first-line triplet therapy (e.g., on clinical trial GOG-182) are eligible
* Must have had debulking surgery
* Tissue blocks from this surgery must be available
* No CNS metastases
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3 times ULN (5 times ULN if there is liver involvement)
* Creatinine ≤ 1.5 times ULN
* Hemoglobin ≥ 9.0 g/dL
* No uncontrolled infection
* No New York Heart Association class III or IV heart failure
* Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiogram
* No seizure disorder
* No other prior or concurrent malignancy in the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior topotecan hydrochloride
* More than 4 weeks since prior surgery or procedure involving the peritoneum or pleura
* CA125 measurements used as basis for enrollment must be made outside of this 4-week window
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
* More than 4 weeks since prior immunotherapy
* More than 4 weeks since prior biologic therapy
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to \> 25 % of bone marrow
* No prior therapy with an anti-epidermal growth factor receptor or anti-HER2 tyrosine kinase inhibitors
* No prior agents targeting topoisomerase I
* No prior or concurrent human anti-mouse antibodies (HAMA) in patients with non-measurable disease
* At least 14 days since prior and no concurrent herbal or dietary supplements
* Vitamin supplements are allowed unless they include herbal additives
* At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
* Rifampin
* Rifabutin
* Rifapentine
* Phenytoin
* Carbamazepine
* Phenobarbital
* Efavirenz
* Nevirapine
* Cortisone (\> 50 mg)
* Hydrocortisone (\> 40 mg)
* Prednisone (\> 10 mg)
* Methylprednisolone (\> 8 mg)
* Dexamethasone (\> 1.5 mg)
* Oral doses of ≤ 1.6 mg of dexamethasone allowed
* Modafinil
* Hypericum perforatum (St. John's wort)
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Itraconazole
* Ketoconazole
* Fluconazole (\> 150 mg daily)
* Voriconazole
* Delaviridine
* Nelfinavir
* Amprenavir
* Ritonavir
* Indinavir
* Saquinavir
* Lopinavir
* Verapamil
* Diltiazem
* Nefazodone
* Fluvoxamine
* Cimetidine
* Aprepitant
* Grapefruit or grapefruit juice
* At least 6 months since prior and no concurrent amiodarone
* No concurrent participation in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, gene therapy) for symptom control or therapeutic intentReferences
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