Combination Therapy With Oral 9-Nitrocamptothecin & Oral Etoposide

NCT00006047 | Completed Phase 1

• 2 other identifiers: MCC-12177NCI-G00-1821
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Determine the MTD of nitrocamptothecin. Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

  3 years

Study Arms (1)

Combination Therapy

EXPERIMENTAL

Combination Therapy with Oral 9-Nitrocamptothecin \& Oral Etoposide. Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: Oral Etoposide; Drug: Oral 9-Nitrocamptothecin

Interventions

Oral Etoposide DRUG

Also known as: Vepesid, Oral VP-16

Combination Therapy

Oral 9-Nitrocamptothecin DRUG

Also known as: rubitecan, 9NC, oral topoisomerase I inhibitor, PEG-1000

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed nonhematologic malignancy refractory to available therapies or for which no curative therapy exists Measurable or evaluable disease No active brain metastases, including evidence of cerebral edema by CT scan or MRI, progression from a prior imaging study, or any requirement for steroids or clinical symptoms of/from brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL ALT and AST less than 2 times upper limit of normal (ULN) (unless clearly related to hepatic metastases) Renal: Creatinine less than 1.5 times ULN Other: No other serious uncontrolled medical disorder or active infection that would preclude study No dementia or altered mental status that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 10 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent colony stimulating factors (e.g., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No prior topoisomerase I inhibitors (e.g., nitrocamptothecin, aminocamptothecin, irinotecan, or topotecan) At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas, mitomycin, or carboplatin) No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy No concurrent hormonal anticancer therapy Radiotherapy: At least 4 weeks since prior radiotherapy involving at least 30% of the bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental anticancer medication

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• Astex Pharmaceuticals, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Interventions

Etoposide; rubitecan; Topoisomerase I Inhibitors; tocophersolan

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Daniel M. Sullivan, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: February 12, 2004
• Study Start: June 1, 2000
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

US (1)