CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Paclitaxel; Paclitaxel poliglumex

Criteria

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