CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: paclitaxel poliglumex |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma |
| Study Start Date: | February 2001 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103.
- Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103.
Patients are followed between 1-3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
Recurrent disease following prior initial therapy with platinum-based regimen
- No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease
- No more than 1 prior non-platinum, non-taxane regimen
- At least 1 site of radiographically measurable disease AND/OR
- CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT less than 1.5 times ULN
- Alkaline phosphatase less than 1.5 times ULN
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs
- No active uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy and recovered
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
- At least 4 weeks since prior endocrine therapy and recovered
Radiotherapy
- At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
Surgery
- Not specified
Other
- At least 4 weeks since other prior investigational drugs and recovered
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Paul Sabbatini, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00017017 History of Changes |
| Other Study ID Numbers: | CDR0000068642, MSKCC-01024, CTI-1071, NCI-G01-1947 |
| Study First Received: | June 6, 2001 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube 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 Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013