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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001426 |
Purpose
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasm |
Drug: Cyclophosphamide Drug: Paclitaxel Drug: Cisplatin Drug: G-CSF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer |
| Enrollment: | 47 |
| Study Start Date: | February 1995 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.
Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.
Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.
Performance status of less than or equal to ECOG 2.
Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.
All patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.
EXCLUSION CRITERIA:
Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).
History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.
Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.
History of active GI bleeding within the last 30 days.
Prior therapy other than surgery for this malignancy.
Abnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.
Previous history of invasive malignancy.
Patients with ureteral obstruction must have this corrected prior to starting therapy.
Patients with germ cell, mixed Muellerian and borderline histologies are specifically excluded.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001426 History of Changes |
| Obsolete Identifiers: | NCT00019045 |
| Other Study ID Numbers: | 950055, 95-C-0055 |
| Study First Received: | November 3, 1999 |
| Last Updated: | February 10, 2012 |
| Health Authority: | United States: Federal Government |
|
Ovarian Cancer Initial Therapy Paclitaxel Cisplatin Cyclophosphamide |
|
Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Cisplatin Cyclophosphamide Paclitaxel Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
