Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: paclitaxel Drug: topotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV |
- Maximum tolerated dose and dose-limiting toxicity of topotecan [ Designated as safety issue: Yes ]
- Toxic effects [ Designated as safety issue: Yes ]
- Antitumor activity [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 1998 |
OBJECTIVES:
- Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00)
- Evaluate the anti-tumor activity of this regimen in this patient population.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00)
- Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer
- Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients)
- No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 9.0 g/dL
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present
- Alkaline phosphatase no greater than 2 times ULN*
- SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present
Renal:
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment
- No myocardial infarction within the past 3 months
Other:
- No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled infection
- No complete bowel obstruction or other condition that would affect GI absorption or motility
- No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated
- No other concurrent medical conditions that would preclude study
- No mental disease
- No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- No prior camptothecin analogue
- No prior chemotherapy for ovarian cancer
- No other concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No concurrent hormonal therapy other than estrogen replacement
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 30 days or 5 half-lives since any prior investigational therapy
- No other concurrent investigational therapy
- No concurrent metoclopramide or cisapride
Contacts and Locations| Denmark | |
| Rigshospitalet - Copenhagen University Hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Svend Aage Engelholm, MD 45-3545-4088 saengel@rh.dk | |
| Study Chair: | Svend Aage Engelholm, MD | Rigshospitalet, Denmark |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003732 History of Changes |
| Other Study ID Numbers: | CDR0000066847, DAN-104864/373, DAN-104864-A/373, EU-98052, SB-104864-A/373, SB-104864/373 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IIB ovarian epithelial cancer stage IIC ovarian epithelial cancer stage IIIA ovarian epithelial cancer |
stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carboplatin Paclitaxel |
Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013