Phase 2
N=18
Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin
Ovarian Cancer · Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00436644 ↗Enrolled (actual)
18
Serious AEs
22.2%
Results posted
Mar 2012
Primary outcome: Primary: Response Rate (Complete Response (CR) or Partial Response (PR)) — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lapatinib (Drug); Topotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Complete Response (CR) or Partial Response (PR)) |
1 | — |
| SECONDARY Time to Progression |
3.5 | — |
| SECONDARY Adverse Event Profile |
7; 5; 1; 2; 4; 1 | — |
| SECONDARY Overall Survival |
15.5 | — |
Summary
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.
Eligibility Criteria
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 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 intent
Data sourced from ClinicalTrials.gov (NCT00436644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.