Clinical trial · Interventional
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT00230542CI-TRIAL-00034310completedPhase 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)
The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, 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 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin / Pemetrexed
- description
- Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2
- interventionNames
- Drug: Carboplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer.
- timeFrame
- 2 years
- description
- This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above. * At least one measurable lesion according to RECIST criteria via CT or MRI scan * Received a platinum-containing regimen at initial diagnosis * ECOG performance status of 0,1 or 2 * 18 years of age or older * Life expectancy of greater than 12 weeks * WBC \> 1,500/mm3 * Neutrophils \> 1,500/mm3 * Platelets \> 100,000/mm3 * Total Bilirubin \< 1.5 ULN * Calculated creatinine clearance \> 45 ml/min * ALT/AST \< 3 x ULN (no liver mets) ALT/AST \< 5 x ULN (with liver mets) * Complete recovery from completion of previous chemotherapy or biologic therapy * Negative pregnancy test and agree to practice effective method of birth control Exclusion Criteria: * Patients with sarcomatous, stromal, or germ cell elements * Prior pelvic radiotherapy \> 25% of bone marrow * Uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs * Past history of bone marrow transplantation or stem cell support * Known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants * Prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years * Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks * Clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months * Uncontrolled hypercalcemia or diabetes mellitus * Any signs of intestinal obstruction with bowel function and/or nutrition * Grade 2 or greater peripheral neuropathy * Participation in an investigational study within three weeks * History of anaphylactic shock to prior platinum chemotherapy * History of psychiatric disability or other central nervous system disorder
References
Publications (0)
Data not yet available
No reference posted for this study.