Clinical trial · Interventional

Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity

Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity

NCT00003548CI-TRIAL-00004613completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
aminocamptothecin colloidal dispersion	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS: Histologically confirmed advanced malignancy involving the peritoneal cavity, excluding leukemia and lymphoma Patients with ovarian cancer must have received prior standard therapy Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology Other gynecological tumors Breast cancer Gastric cancer Colorectal cancer Appendiceal cancer Pancreatic cancer Unknown primary cancer Other malignancies with predominantly intraperitoneal manifestation No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy No symptomatic disease outside the peritoneal cavity Asymptomatic disease outside the peritoneum considered (e.g., bone lesions)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Aug 1, 1998
Primary completion: Dec 1, 2001
Completion: —
First posted: Feb 20, 2004
Last update posted: Mar 28, 2011
Enrollment: 20 (estimated)
Lead sponsor: NYU Langone Health OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV anal cancer, recurrent anal cancer, stage IV esophageal cancer, recurrent esophageal cancer, stage IV cervical cancer, recurrent cervical cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage IV vulvar cancer, recurrent vulvar cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent vaginal cancer, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent gestational trophoblastic tumor, stage IV endometrial carcinoma, recurrent endometrial carcinoma, unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, carcinoma of the appendix, fallopian tube cancer, stage IV uterine sarcoma, recurrent uterine sarcoma, recurrent carcinoma of unknown primary, stage IV pancreatic cancer

Data updated 22 days agoSource updated Mar 28, 2011

Brief summary (as posted)

Conditions (1)

Interventions (1)

Eligibility (as posted)

Publications (0)

Locations by country (1)